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Consumer Health Data

This Consumer Health Data Privacy Policy (“Privacy Policy”) applies to Washington residents (“Consumers” or “you”) and provides information regarding what consumer health data Autolus and its affiliated entities (referred to collectively as “Autolus,” “we,” “our,” or “us”) collect about you, in connection with our products, services, apps and websites both online and offline (collectively, the “Services”) the sources from which we collect such data, the purposes for which we use and disclose this information, and how you can exercise certain rights with respect to such data.

1. Categories of Consumer Health Data We Collect

As part of the information we may collect or receive about you (as further described in the Autolus Privacy Policy) we may collect and process certain information about you that could identify past, present or future physical or mental health status (“Consumer Health Data”). This Consumer Health Data generally includes:

  • Biographical and demographic information to the extent related to physical or mental health status, diagnosis, disease, or treatment.
  • Health and medical information (such as information about physical and mental health conditions and diagnoses, treatments for medical conditions, genetic information, family medical history, medications an individual may take, including the dosage, timing, and frequency, and information about an individual’s healthcare providers) we collect in connection with recruiting for clinical trials, conducting certain types of research activities (e.g. market research), providing patient support and access programs, and distributing and marketing our products and Services.
  • Location data including precise location information about a particular individual or device.
  • Financial information and transaction data, including purchase history (such as insurance, billing, payment and other transactional information, income, and information to determine eligibility for patient assistance programs and services).
  • Records of your communications and other requests. For example, if you email, call, or otherwise communicate with us or with members of our team (e.g., when you fill out a form on one of our websites or sign up for news and updates from us).
  • Registration information. When you register for certain Services (such as if you participate in promotions or register for events or programs that we sponsor or administer).
  • Information we may collect via automated means or derive about you, which could include inferences about your health or medical status derived or extrapolated from non-Consumer Health Data. Such information may include your device and browser information, activities, and usage data about your use of our Services, and location information derived from your IP address or (with your permission) your mobile device.

2. Sources of Consumer Health Data

We collect your Consumer Health Data from the following sources:

  • Directly from you when you access or use our Services or communicate with us about our business or our Services.
  • When permitted and through our use of cookies and other automatic data collection technologies, when you visit our websites, use our mobile applications, open or click on emails we send you, or interact with our advertisements. We or third parties we work with may automatically collect certain information using technologies such as cookies, web beacons, clear GIF, pixels, internet tags, web server logs, and other data collection tools.
  • From healthcare professionals.
  • From government agencies and/or public records.
  • From service providers, data brokers, or business partners.
  • From industry and patient groups and associations.
  • From publicly available sources, including information provided on websites, social media channels, public forums or platforms, and other third-party sources.

3. How We Use Consumer Health Data

In general, Autolus uses Consumer Health Data for the following purposes:

  • Providing Services and support. To provide and make available our Services, to communicate with you about your use of and interactions with our Services, to respond to your inquiries, to fulfill your orders and requests, and for other customer and patient support purposes. For example:
    • Where you have requested information regarding participation in a clinical trial with Autolus or one of Autolus’s partners
    • To support disease management, education, or decision support systems related to the use of our products and Services
    • Where you have requested a Service from Autolus, assisting you in the completion of your application, the assessment of your eligibility for any such requested Services, the fulfillment of the Services, as well as any applicable renewal of such Services
    • Making proposals for future Service needs
  • Quality, safety and regulatory reporting. We may record and report on the health and other information that we collect associated with product safety or quality, and other adverse incident reports in compliance with our legal regulatory obligations. We may also contact you to seek additional information from individuals who report or communicate such product safety, quality, and other adverse incident information, in order to fulfill our legal and regulatory obligations. The information you provide Autolus is very important and will be used in the safety monitoring of our products for reporting and public health purposes. Please visit the Adverse Event Reporting page to learn more about our practices related to such information.
  • Research and analytics. For purposes of conducting research and analytics to understand, improve, evaluate, and develop our Services and business processes and to develop other insights. For example, we may conduct primary and secondary research related to our clinical products and treatments and related Services, including by recruiting for and conducting clinical trials and to research and develop new products and treatments and other Services. We may administer surveys and questionnaires for market research or quality and satisfaction purposes. We also use Consumer Health Data that we collect about your use of our Services to better understand how users access and use these Services and for other research and analytical purposes, such as to evaluate and improve our Services and business operations, to develop new Services and features, and for internal quality control and training purposes. We may also analyze public sources, such as websites and social media channels, for information related to or reported about us and our Services.
  • Customization and personalization. To tailor content we may send or display on our Services, including to offer location customization and personalized help and instructions, and to otherwise personalize your experiences.
  • Marketing and advertising. As permitted under applicable law, we use certain Consumer Health Data for marketing and advertising purposes, in accordance with applicable law. For example, to send you information about our Services, such as offers, promotions, newsletters and other information we think may interest you, as well as any other information that you sign up to receive. We also may use certain information we collect to manage and improve our marketing and advertising.
  • Planning and managing events. For event planning and management, including registration, attendance, connecting you with other event attendees, event feedback, and contacting you about relevant events and Services.
  • Security and protection of rights. To protect our business and our Services; to prevent and detect fraud, unauthorized activities and access, and/or other misuse; and where we believe necessary to investigate, prevent or take action regarding illegal activities, suspected fraud, situations involving potential threats to the safety or legal rights of any person or third party, or violations of our terms of services and other agreements with you.
  • Compliance with law and legal process. To respond to legal processes and related to legal proceedings, as well as for regulatory reporting and recordkeeping purposes (such as adverse event reporting and tracking or to ensure that we are not precluded from doing business with you).
  • General business and operational support. To operate our business, consider and implement mergers, acquisitions, reorganizations, bankruptcies, and other business transactions, and otherwise related to the administration and/or planning of our general business, accounting, auditing, compliance, recordkeeping, and legal functions.

4. The Categories of Consumer Health Data that We Share

We share or disclose all of the categories of Consumer Health Data that we collect, as disclosed above in section 1.

5. The Parties With Whom We Share or Otherwise Disclose Consumer Health Data

Generally, and as permitted, we share or disclose the Consumer Health Data we collect as described in this section with:

  • Service providers who assist us in the provision of programs and Services
  • Third party business partners with whom we conduct joint business activities
  • Third parties with whom we have marketing arrangements
  • Third parties that help administer, manage, and analyze our programs and Services
  • Third party platforms, providers and networks
  • Third parties in connection with business transactions
  • Third parties for product quality and safety and adverse incident reporting
  • Third parties to comply with our general legal obligations
  • Third parties for security and protection of rights
  • Third parties that process your Consumer Health Data at your direction

6. Your Privacy Rights

If this Privacy Policy is applicable to you, you may have certain rights with respect to Autolus’s use and disclosure of your Consumer Health Data:

  • Right of Access
    You have the right to confirm whether we are collecting, sharing, or selling Consumer Health Data about you and access such data, including a list of all third parties (which does not include authorized service providers) and affiliates with whom Autolus has shared or sold (if applicable) Consumer Health Data and an active email address or other online mechanism that you may use to contact these third parties.
  • Right to Withdraw Consent
    You have the right to withdraw your consent previously provided with regard to our collection and sharing of your Consumer Health Data.
  • Right to Deletion
    You have the right to request that we delete your Consumer Health Data we collect from you.

To help us respond to your request, all communications to Autolus should include the sender’s name and contact information (such as email address, phone number or mailing address), and a detailed explanation of the request. In addition, communications related to Autolus websites should include, as applicable, the email address used for registration and the Autolus website address on which Consumer Health Data was provided (e.g., www.autolus.com). Autolus will endeavor to respond to all reasonable requests in a timely manner, and in any case, within any time limits prescribed by applicable local law.

You may also contact us by telephone at T +44 (0)20 3829 6230.

London
CORPORATE HEADQUARTERS
Autolus Ltd
The Mediaworks
191 Wood Lane
White City
London
W12 7FP
VAT No. 199507653
Company No. 09115837
T +44 (0)20 3829 6230
E contact@autolus.com

If you request an appeal of a denial of rights under the Washington My Health My Data Act and the appeal is denied, you may raise a concern or lodge a complaint with the Washington State Attorney General at www.atg.wa.gov/file-complaint.

Supplement to Consumer Health Data Privacy Policy for Nevada Consumers

This Supplement applies to Nevada consumers for purposes of providing additional disclosures required by Nevada's Consumer Health Data privacy law.

Purposes and Manner of Processing.

We collect, use, process, and share Consumer Health Data for the purposes and in the manners described in sections 1 through 5 of our Autolus Consumer Health Data Privacy Policy, which also provides additional disclosures relevant to Nevada Consumers.

Review and Revision of Consumer Health Data.

If you would like to review and/or revise your Consumer Health Data, you may submit a request to us via any of the methods listed in our Autolus Consumer Health Data Privacy Policy. We will respond to your request to exercise your rights in accordance with applicable law.

Changes to this Supplement.

We will notify of changes to our privacy practices with respect to your Consumer Health Data by posting an updated Privacy Policy on this page, with an updated effective date.

Third Party Collection of Consumer Health Data.

We may use third parties, including cookie providers and other online trackers, to collect your Consumer Health Data over time and across different websites or online services when you use our websites or online services. Please see our Cookie Statement for more information regarding our use of cookies and your choices.

IMPORTANT SAFETY INFORMATION

More

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

  • Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS.
  • Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal and life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed.

INDICATION

AUCATZYL® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

  • Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS.
  • Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal and life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.

WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS)

Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days following the first infusion (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). The most common manifestations of CRS included fever (100%), hypotension (35%), and hypoxia (19%).

Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. During and following treatment with AUCATZYL, closely monitor patients for signs and symptoms of CRS daily for at least 14 days at the healthcare facility following the first infusion. Continue to monitor patients for CRS for at least 4 weeks following each infusion with AUCATZYL. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate the patient for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.

Neurologic Toxicities

Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which were fatal or life-threatening, occurred following treatment with AUCATZYL. Neurologic toxicities were reported in 64% (64/100) of patients, including Grade ≥ 3 in 12% of patients. The median time to onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a median duration of 13 days (range: 1 to 904 days). Among patients with neurologic toxicities, the most common symptoms (> 5%) included ICANS (38%), headache (34%), encephalopathy (33%), dizziness (22%), tremor (13%), anxiety (9%), insomnia (9%), and delirium (8%).

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)

ICANS events occurred in 24% (24/100) of patients, including Grade ≥ 3 in 7% (7/100) of patients. Of the 24 patients who experienced ICANS, 33% (8/24) experienced an onset after the first infusion, but prior to the second infusion of AUCATZYL.

The median time to onset for ICANS events after the first infusion was 8 days (range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) after the second infusion, with a median duration of 8.5 days (range: 1 to 53 days).

Eighty-eight percent (21/24) of patients received treatment for ICANS. All treated patients received high-dose corticosteroids and 42% (10/24) of patients received anti-epileptics prophylactically. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage ICANS.

Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity /ICANS, immediately evaluate patients for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.

Effect on Ability to Drive and Use Machines

Due to the potential for neurologic events, including altered mental status or seizures, patients receiving AUCATZYL are at risk for altered or decreased consciousness or coordination in the eight weeks following AUCATZYL infusion or until resolution of the neurological event by the treating physician. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Prolonged Cytopenias

Patients may exhibit cytopenias including anemia, neutropenia, and thrombocytopenia for several weeks after treatment with lymphodepleting chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade ≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were observed in 71% (29/41) of patients and included neutropenia (66%, 27/41) and thrombocytopenia (54%, 22/41). Grade 3 or higher cytopenias that persisted beyond Day 60 following AUCATZYL infusion was observed in 27% (11/41) of patients and included neutropenia (17%, 7/41) and thrombocytopenia (15%, 6/41). Monitor blood counts after AUCATZYL infusion.

Infections

Severe, including life-threatening and fatal infections occurred in patients after AUCATZYL infusion. Non-COVID-19 infections of all grades occurred in 67% (67/100) of patients. Grade 3 or higher non-COVID-19 infections occurred in 41% (41/100) of patients. AUCATZYL should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after AUCATZYL infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Grade 3 or higher febrile neutropenia was observed in 26% (26/100) of patients after AUCATZYL infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Viral reactivation, potentially severe or life-threatening, can occur in patients treated with drugs directed against B cells. There is no experience with manufacturing AUCATZYL for patients with a positive test for human immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Hypogammaglobulinemia

Hypogammaglobulinemia and B-cell aplasia can occur in patients after AUCATZYL infusion. Hypogammaglobulinemia was reported in 10% (10/100) of patients treated with AUCATZYL including Grade 3 events in 2 patients (2%).

Immunoglobulin levels should be monitored after treatment with AUCATZYL and managed per institutional guidelines including infection precautions, antibiotic or antiviral prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following treatment with AUCATZYL has not been studied. Vaccination with live viral vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until immune recovery following treatment with AUCATZYL.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)

HLH/MAS including fatal and life-threatening reactions occurred after treatment with AUCATZYL. HLH/MAS was reported in 2% (2/100) of patients and included Grade 3 and Grade 4 events with a time of onset at Day 22 and Day 41, respectively. One patient experienced a concurrent ICANS event after AUCATZYL infusion and died due to sepsis with ongoing HLH/MAS that had not resolved. Administer treatment for HLH/MAS according to institutional standards.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for hypersensitivity reactions during and after AUCATZYL infusion.

Secondary Malignancies

Patients treated with AUCATZYL may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Autolus at 1-855-288-5227 for reporting and to obtain instructions on the collection of patient samples for testing.

Adverse Reactions

The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 106 CD19 CAR-positive viable T cells (range: 10 to 480 × 106 CD19 CAR-positive viable T cells with 90% of patients receiving the recommended dose of 410 × 106 +/- 25%).

The most common serious adverse reactions of any Grade (incidence ≥ 2%) included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS, fever, bacterial infectious disorders, encephalopathy, fungal infections, hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and hypoxia. Nine patients (9%) experienced fatal adverse reactions which included infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism, acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients, five patients who died from infections had pre-existing and ongoing neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy treatment and/or AUCATZYL.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

INDICATION

AUCATZYL® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

  • Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS.
  • Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal and life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.

WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS)

Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days following the first infusion (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). The most common manifestations of CRS included fever (100%), hypotension (35%), and hypoxia (19%).

Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. During and following treatment with AUCATZYL, closely monitor patients for signs and symptoms of CRS daily for at least 14 days at the healthcare facility following the first infusion. Continue to monitor patients for CRS for at least 4 weeks following each infusion with AUCATZYL. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate the patient for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.

Neurologic Toxicities

Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which were fatal or life-threatening, occurred following treatment with AUCATZYL. Neurologic toxicities were reported in 64% (64/100) of patients, including Grade ≥ 3 in 12% of patients. The median time to onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a median duration of 13 days (range: 1 to 904 days). Among patients with neurologic toxicities, the most common symptoms (> 5%) included ICANS (38%), headache (34%), encephalopathy (33%), dizziness (22%), tremor (13%), anxiety (9%), insomnia (9%), and delirium (8%).

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)

ICANS events occurred in 24% (24/100) of patients, including Grade ≥ 3 in 7% (7/100) of patients. Of the 24 patients who experienced ICANS, 33% (8/24) experienced an onset after the first infusion, but prior to the second infusion of AUCATZYL.

The median time to onset for ICANS events after the first infusion was 8 days (range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) after the second infusion, with a median duration of 8.5 days (range: 1 to 53 days).

Eighty-eight percent (21/24) of patients received treatment for ICANS. All treated patients received high-dose corticosteroids and 42% (10/24) of patients received anti-epileptics prophylactically. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage ICANS.

Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity /ICANS, immediately evaluate patients for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.

Effect on Ability to Drive and Use Machines

Due to the potential for neurologic events, including altered mental status or seizures, patients receiving AUCATZYL are at risk for altered or decreased consciousness or coordination in the eight weeks following AUCATZYL infusion or until resolution of the neurological event by the treating physician. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Prolonged Cytopenias

Patients may exhibit cytopenias including anemia, neutropenia, and thrombocytopenia for several weeks after treatment with lymphodepleting chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade ≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were observed in 71% (29/41) of patients and included neutropenia (66%, 27/41) and thrombocytopenia (54%, 22/41). Grade 3 or higher cytopenias that persisted beyond Day 60 following AUCATZYL infusion was observed in 27% (11/41) of patients and included neutropenia (17%, 7/41) and thrombocytopenia (15%, 6/41). Monitor blood counts after AUCATZYL infusion.

Infections

Severe, including life-threatening and fatal infections occurred in patients after AUCATZYL infusion. Non-COVID-19 infections of all grades occurred in 67% (67/100) of patients. Grade 3 or higher non-COVID-19 infections occurred in 41% (41/100) of patients. AUCATZYL should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after AUCATZYL infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Grade 3 or higher febrile neutropenia was observed in 26% (26/100) of patients after AUCATZYL infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Viral reactivation, potentially severe or life-threatening, can occur in patients treated with drugs directed against B cells. There is no experience with manufacturing AUCATZYL for patients with a positive test for human immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Hypogammaglobulinemia

Hypogammaglobulinemia and B-cell aplasia can occur in patients after AUCATZYL infusion. Hypogammaglobulinemia was reported in 10% (10/100) of patients treated with AUCATZYL including Grade 3 events in 2 patients (2%).

Immunoglobulin levels should be monitored after treatment with AUCATZYL and managed per institutional guidelines including infection precautions, antibiotic or antiviral prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following treatment with AUCATZYL has not been studied. Vaccination with live viral vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until immune recovery following treatment with AUCATZYL.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)

HLH/MAS including fatal and life-threatening reactions occurred after treatment with AUCATZYL. HLH/MAS was reported in 2% (2/100) of patients and included Grade 3 and Grade 4 events with a time of onset at Day 22 and Day 41, respectively. One patient experienced a concurrent ICANS event after AUCATZYL infusion and died due to sepsis with ongoing HLH/MAS that had not resolved. Administer treatment for HLH/MAS according to institutional standards.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for hypersensitivity reactions during and after AUCATZYL infusion.

Secondary Malignancies

Patients treated with AUCATZYL may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Autolus at 1-855-288-5227 for reporting and to obtain instructions on the collection of patient samples for testing.

Adverse Reactions

The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 106 CD19 CAR-positive viable T cells (range: 10 to 480 × 106 CD19 CAR-positive viable T cells with 90% of patients receiving the recommended dose of 410 × 106 +/- 25%).

The most common serious adverse reactions of any Grade (incidence ≥ 2%) included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS, fever, bacterial infectious disorders, encephalopathy, fungal infections, hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and hypoxia. Nine patients (9%) experienced fatal adverse reactions which included infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism, acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients, five patients who died from infections had pre-existing and ongoing neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy treatment and/or AUCATZYL.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.