This section highlights FDA-related milestones and regulatory updates for drugs developed by Autolus Therapeutics (AUTL).
Over the past two years, Autolus Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
obe-cel, AUCATZYL, and Obe-cel. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Obe-cel FDA Regulatory Timeline and Events
Obe-cel is a drug developed by Autolus Therapeutics for the following indication: adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- obe-cel
- Announced Date:
- December 8, 2025
- Indication:
- adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL).
Announcement
Autolus Therapeutics plc announces presentation of preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients, as well as further insights from the registrational FELIX study in adult r/r B-ALL, at the American Society of Hematology (ASH) Annual Meeting.
Read Announcement- Drug:
- obe-cel
- Announced Date:
- October 27, 2025
- Indication:
- adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL).
Announcement
Autolus Therapeutics plc announces that follow-up data from the ongoing CARLYSLE trial, a Phase 1 dose confirmation clinical trial of obe-cel in severe refractory systemic lupus erythematosus (srSLE), will be presented during a poster session at the American College of Rheumatology Convergence 2025.
AI Summary
Autolus Therapeutics will present follow-up data from its Phase 1 CARLYSLE trial of obe-cel in severe refractory systemic lupus erythematosus (srSLE) at the American College of Rheumatology Convergence 2025. The poster session will highlight safety and early efficacy findings in this difficult-to-treat patient group.
In six patients treated with a 50 million-cell dose, obe-cel was well tolerated with no immune effector cell-associated neurotoxicity syndrome (ICANS) or grade ≥2 cytokine release syndrome (CRS). Preliminary results showed 83% achieved remission by the Definition of Remission in SLE (DORIS) and 50% had a complete renal response (CRR). All remissions remained ongoing at a median 8.9-month follow-up, and glucocorticosteroids were tapered to 5 mg/day by month six.
All participants had refractory lupus nephritis and received no other lupus therapy. Autolus plans to dose the first patient in its Phase 2 pivotal study in lupus nephritis before the end of 2025.
Read Announcement- Drug:
- obe-cel
- Announced Date:
- October 20, 2025
- Indication:
- adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL).
Announcement
Autolus Therapeutics plc announces that the first patient has been dosed in its Phase 1 BOBCAT trial of obecabtagene autoleucel (obe-cel) in patients with progressive multiple sclerosis (PMS).
AI Summary
Autolus Therapeutics, an early-stage biotech, announced the first dosing of a patient with progressive multiple sclerosis in its Phase 1 BOBCAT trial of obecabtagene autoleucel (obe-cel) at University College London Hospitals NHS Foundation Trust. This single CAR T cell therapy aims to deplete central nervous system B cells and reduce autoimmune inflammation driving the disease. Wallace Brownlee, the trial’s principal investigator, said obe-cel’s approach could transform outcomes for MS patients who keep worsening despite current B-cell treatments.
The BOBCAT trial will enroll up to 18 adults with refractory progressive MS to assess obe-cel’s safety, tolerability and early signs of benefit. Primary endpoints are safety and tolerability, with preliminary efficacy evaluated using standard MS measures. Autolus Chief Development Officer Dr. Matthias Will said obe-cel’s fast-off rate CAR design, studied in over 400 patients, offers hope for new treatment options in MS.
Read Announcement- Drug:
- obe-cel
- Announced Date:
- May 23, 2025
- Indication:
- adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL).
Announcement
Autolus Therapeutics announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended European Commission (EC) approval of obecabtagene autoleucel (obe-cel) for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
AI Summary
Autolus Therapeutics announced that the European Medicines Agency’s CHMP has recommended that the European Commission approve obecabtagene autoleucel (obe-cel) for adult patients aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This recommendation is based on data from the FELIX clinical trial, which showed that obe-cel offered high and lasting response rates with low toxicity in a difficult-to-treat patient group. The trial demonstrated a complete response rate of about 76.6% and promising long-term outcomes, indicating that obe-cel could provide a valuable treatment option for patients with a poor prognosis. The EC decision on the conditional marketing authorization is expected within approximately two months, which would make obe-cel available to patients across the European Union, Iceland, Norway, and Liechtenstein.
Read Announcement- Drug:
- obe-cel
- Announced Date:
- May 14, 2025
- Indication:
- adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL).
Announcement
Autolus Therapeutics announces the online publication of three abstracts submitted to the European Hematology Association (EHA) Congress, to be held June 12-15, 2025, Milan, Italy.
AI Summary
Autolus Therapeutics has announced the online publication of three abstracts that will be presented at the European Hematology Association (EHA) Congress in Milan, Italy, from June 12 to 15, 2025. The company plans two oral presentations and one poster session showcasing data on its CAR-T therapy, obecabtagene autoleucel (obe-cel), for adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). In one oral presentation, researcher Jae H. Park discusses long-term findings from the FELIX study, including factors such as low disease burden and early intervention that are linked to better outcomes, with 40% of responders maintaining remission without additional therapies. Another oral session by Bijal D. Shah highlights favorable treatment outcomes and a consistent safety profile across different age groups. The poster presentation, led by Claire Roddie, evaluates predictive models for hematotoxicity risk in patients treated with obe-cel.
Read Announcement
AUCATZYL FDA Regulatory Timeline and Events
AUCATZYL is a drug developed by Autolus Therapeutics for the following indication: For the treatment of hematological malignancies, solid tumors and autoimmune diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AUCATZYL
- Announced Date:
- November 25, 2025
- Indication:
- For the treatment of hematological malignancies, solid tumors and autoimmune diseases.
Announcement
Autolus Therapeutics plc announces that the National Institute for Health and Care Excellence (NICE) has published draft guidance1 recommending AUCATZYL® (obecabtagene autoleucel, or "obe-cel")2 for use in the National Health Service (NHS) in England and Wales as a treatment option for adult patients (≥26 years) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
AI Summary
The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending AUCATZYL (obecabtagene autoleucel, or "obe-cel") for use in the NHS in England and Wales as a treatment option for adults (≥26 years) with relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (r/r B‑ALL).
Autolus says AUCATZYL will be available through routine NHS commissioning and intends to launch in England and Wales imminently. The company also plans to seek patient access in Scotland via the Scottish Medical Consortium.
The UK Medicines and Healthcare products Regulatory Agency granted conditional marketing authorisation in April 2025. That decision was based on results from the FELIX study, a multi‑centre, single‑arm trial published in the New England Journal of Medicine.
Patient groups such as Anthony Nolan and Leukaemia UK welcomed the draft recommendation. AUCATZYL is an autologous CD19 CAR T cell therapy developed with researchers at University College London and Great Ormond Street Hospital.Read Announcement
- Drug:
- AUCATZYL
- Announced Date:
- July 21, 2025
- Indication:
- For the treatment of hematological malignancies, solid tumors and autoimmune diseases.
Announcement
Autolus Therapeutics plc announced that the European Commission (EC) has granted marketing authorization for AUCATZYL® (obecabtagene autoleucel or "obe-cel") for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
AI Summary
Autolus Therapeutics announced that the European Commission has granted marketing authorization for AUCATZYL® (obecabtagene autoleucel or “obe-cel”) to treat adult patients aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The approval covers all 27 EU member states, plus Iceland, Norway and Liechtenstein.
This decision was based on the FELIX clinical trial, which enrolled 127 adult r/r B-ALL patients. In the pivotal cohort of 94 patients, 76.6% achieved a complete response or complete response with incomplete blood recovery (CR/CRi). The median duration of response was 21.2 months, and six- and twelve-month event-free survival rates were 65.4% and 49.5%, respectively.
Safety data showed manageable toxicity. The most common serious adverse events included infections (32%), febrile neutropenia (24%) and bacterial infections (11%). Cytokine release syndrome occurred in 68.5% of patients, mostly grades 1–2. Autolus will now evaluate market entry opportunities across Europe.
Read Announcement- Drug:
- AUCATZYL
- Announced Date:
- April 25, 2025
- Indication:
- For the treatment of hematological malignancies, solid tumors and autoimmune diseases.
Announcement
Autolus Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for AUCATZYL® (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
AI Summary
Autolus Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for AUCATZYL® (obecabtagene autoleucel). This new “conditional marketing authorisation” means the MHRA will review additional efficacy and safety data on an annual basis. The approval is based on the FELIX clinical trial, which tested the therapy in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
Doctors and researchers involved in the FELIX study expressed optimism that the treatment will soon become accessible to eligible patients, especially with ongoing assessments by the National Institute for Health and Care Excellence (NICE). AUCATZYL was designed to address the unmet need in adult r/r B-ALL, offering a promising new option for patients battling this aggressive form of cancer.
Read Announcement- Drug:
- AUCATZYL
- Announced Date:
- March 24, 2025
- Indication:
- For the treatment of hematological malignancies, solid tumors and autoimmune diseases.
Announcement
Agilent Technologies Inc. announce its role in supporting Autolus Therapeutics' FDA approval for AUCATZYL®, a recently approved CAR T therapy.
AI Summary
Agilent Technologies has played a key role in advancing Autolus Therapeutics’ CAR T therapy, AUCATZYL, by supporting its FDA approval. The company’s xCELLigence Real-Time Cell Analysis (RTCA) technology was used to develop and validate the potency assay for AUCATZYL. This cutting-edge technology continuously monitors cell behavior and measures electrical impedance, ensuring accurate, reliable, and real‐time data throughout the testing process. Such precise cell analysis supported the stringent FDA requirements and helped demonstrate the therapy’s potency and consistency. Both Agilent and Autolus have praised the collaboration, emphasizing how innovative analytical tools and strategic partnerships contribute to breakthrough cancer treatments. This milestone not only highlights Agilent’s commitment to advancing scientific innovation but also showcases how state-of-the-art technology can accelerate the development of effective therapies, ultimately improving health outcomes for patients in need.Read Announcement
- Drug:
- AUCATZYL
- Announced Date:
- March 20, 2025
- Indication:
- For the treatment of hematological malignancies, solid tumors and autoimmune diseases.
Announcement
Autolus Therapeutics provided Business Updates
AI Summary
Autolus Therapeutics recently provided key updates on its business progress. The company highlighted a strong finish in 2024 with strategic milestones, including a partnership with BioNTech and the ramp-up of its in-house CAR T manufacturing facility. Autolus emphasized its ongoing commercial success, noting that 33 U.S. treatment centers are now authorized, with plans to expand further by the end of the year to better serve the target patient population.
Looking ahead, the company is committed to growing its clinical pipeline. It plans to share initial data from its Phase 1 dose confirmation trial in patients with systemic lupus erythematosus (SLE) and to outline further investments aimed at expanding the obe-cel opportunity. These business updates and expansion plans will be discussed in more detail at an upcoming R&D investor event on April 23, 2025.
Read Announcement- Drug:
- AUCATZYL
- Announced Date:
- January 17, 2025
- Indication:
- For the treatment of hematological malignancies, solid tumors and autoimmune diseases.
Announcement
Autolus Therapeutics plc announces an oral presentation and three poster presentations accepted to the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held from February 12-15, 2025, in Hawai'i Convention Center, Honolulu, HI.
AI Summary
Autolus Therapeutics plc announced that an oral presentation and three poster presentations have been accepted for the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, scheduled for February 12-15, 2025, at the Hawai‘i Convention Center in Honolulu, HI. The presentations will include updated data and analyses on the company’s CAR-T therapy, AUCATZYL®. In one oral session, researchers will discuss risk factors linked to sub-optimal outcomes and hematotoxicity in patients treated with obe-cel. The poster sessions will cover an economic model comparing adverse event costs, highlighting that a shorter duration and lower incidence of CRS and ICANS with AUCATZYL® could reduce healthcare costs. Additional research will explore the relationship between deep molecular remissions and improved clinical outcomes, underscoring the potential benefits of the therapy in treating relapsed or refractory B-cell acute lymphoblastic leukemia.
Read Announcement
Obe-cel (AUTO1 - ALLCAR19) ALL FDA Regulatory Timeline and Events
Obe-cel (AUTO1 - ALLCAR19) ALL is a drug developed by Autolus Therapeutics for the following indication: Adult Acute lymphoblastic leukemia (ALL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Obe-cel (AUTO1 - ALLCAR19) ALL
- Announced Date:
- January 17, 2025
- Target Action Date:
- February 13, 2025
- Indication:
- Adult Acute lymphoblastic leukemia (ALL)
Announcement
Autolus Therapeutics plc announces an oral presentation and three poster presentations accepted to the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held from February 12-15, 2025, in Hawai'i Convention Center, Honolulu, HI.
AI Summary
Autolus Therapeutics plc announced that it will present new research at the upcoming 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR. These meetings will take place from February 12-15, 2025, at the Hawai‘i Convention Center in Honolulu, HI.
The company has been accepted to deliver one oral presentation and three poster presentations. The oral session will focus on the risk factors associated with sub-optimal outcomes and hematotoxicity in patients with relapsed or refractory B-Cell Acute Lymphoblastic Leukemia treated with its CAR T-cell therapy, obe-cel. The posters will cover an updated health economic cost model comparing adverse event costs, efficacy comparisons of obe-cel versus standard care, and the impact of deep molecular remissions on long-term clinical outcomes. This presentation marks an important opportunity for Autolus to showcase new data and insights to the global medical community.
Read Announcement- Drug:
- Obe-cel (AUTO1 - ALLCAR19) ALL
- Announced Date:
- December 9, 2024
- Indication:
- Adult Acute lymphoblastic leukemia (ALL)
Announcement
Autolus Therapeutics announces an oral presentation and three poster presentations at the American Society of Hematology (ASH) Annual Meeting, being held from December 7-10, 2024, in San Diego.
AI Summary
Autolus Therapeutics announced that it will present new clinical data at the American Society of Hematology (ASH) Annual Meeting in San Diego from December 7-10, 2024. The company will deliver an oral presentation that details the results from the FELIX trial, showing that treatment with obe-cel produced a high rate of deep molecular remission in adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL). This deep remission is linked to better patient outcomes, including longer event-free and overall survival. In addition to the oral presentation, Autolus will present three posters. These posters will cover the impact of different bridging therapies on CAR T-cell expansion, the potential for reducing healthcare costs by lessening severe side effects, and the use of hematotoxicity scores to identify patients who may be at higher risk for treatment complications.
Read Announcement- Drug:
- Obe-cel (AUTO1 - ALLCAR19) ALL
- Announced Date:
- December 2, 2024
- Indication:
- Adult Acute lymphoblastic leukemia (ALL)
Announcement
Autolus Therapeutics announces that the New England Journal of Medicine has published data from the pivotal Phase 1b/2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL).
AI Summary
Autolus Therapeutics announced that the New England Journal of Medicine has published data from the pivotal Phase 1b/2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia. In the study, about 77% of patients reached complete remission or complete remission with incomplete blood recovery. The data also showed that the treatment had a low incidence of severe immune-related side effects, with only 2.4% experiencing high-grade cytokine release syndrome and 7.1% having severe neurotoxicity. Additionally, nearly half of all treated patients showed event-free survival at 12 months. These promising results suggest that obe-cel could offer a durable and effective option for adults with this aggressive form of leukemia, potentially redefining treatment standards in the relapsed/refractory setting.
Read Announcement- Drug:
- Obe-cel (AUTO1 - ALLCAR19) ALL
- Announced Date:
- August 27, 2024
- Indication:
- Adult Acute lymphoblastic leukemia (ALL)
Announcement
Autolus Therapeutics announces a poster presentation at the Society of Hematologic Oncology (SOHO) Annual Meeting being held September 4-7, 2024 in Houston, Texas.
AI Summary
Autolus Therapeutics announced an upcoming poster presentation at the Society of Hematologic Oncology (SOHO) Annual Meeting in Houston, Texas, scheduled for September 4-7, 2024. The presentation will focus on their investigational CAR T-cell therapy, obe-cel, for treating relapsed/refractory Adult B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL) using a tumor burden (TB)-guided dosing strategy.
The study, part of the FELIX Phase 1b/2 trial, highlights that administering obe-cel in two doses—regardless of a patient’s TB before lymphodepletion—results in high CAR T-cell expansion and a strong overall remission rate. The poster, entitled "Obecabtagene autoleucel (obe-cel) for Relapsed/Refractory Adult B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL): Impact of CAR T and TB-Guided Dosing," will be presented by Dr. Elias Jabbour at 6:15 pm on September 4, in Hall B3 (Poster Number ALL-502).
Read Announcement- Drug:
- Obe-cel (AUTO1 - ALLCAR19) ALL
- Announced Date:
- June 14, 2024
- Indication:
- Adult Acute lymphoblastic leukemia (ALL)
Announcement
Autolus Therapeutics announces three abstracts to be presented at the European Hematology Association (EHA) Congress, June 13-16, 2024.
AI Summary
Autolus Therapeutics has announced that it will present three abstracts at the upcoming European Hematology Association (EHA) Congress, scheduled for June 13-16, 2024. One abstract will focus on results from the FELIX study, which examined the use of obe-cel in adult patients with relapsed/refractory acute lymphoblastic leukemia. The data, with a median follow-up of 21.5 months, indicate a 78% overall response rate, with roughly 40% of patients maintaining remission without further treatment. The findings suggest that obe-cel may lead to a durable response as a single agent, with both event-free and overall survival showing promising stabilization at around 40%. The other abstracts will explore the impact of inotuzumab-containing bridging therapy and compare methods for measuring CAR T-cell kinetics, further supporting the potential of CAR T treatments in blood cancers.
Read Announcement- Drug:
- Obe-cel (AUTO1 - ALLCAR19) ALL
- Announced Date:
- May 31, 2024
- Indication:
- Adult Acute lymphoblastic leukemia (ALL)
Announcement
Autolus Therapeutics announces longer-term follow-up and additional data analysis from the pivotal Phase 1b/2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), being presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, (May 31 – June 4, 2024, Chicago).
AI Summary
Autolus Therapeutics announced new longer-term follow-up results and additional analysis from its pivotal Phase 1b/2 FELIX study for obecabtagene autoleucel (obe-cel) in adults with relapsed/refractory B-cell Acute Lymphoblastic Leukemia. At a median follow-up of 21 months, the data showed that 40% of patients remained in ongoing remission without needing a stem cell transplant or additional therapy. The study results indicate that the durability of responses may lead to a long-term plateau in survival outcomes. Additionally, ongoing CAR T cell persistence was linked to improved event-free survival, further supporting the potential of obe-cel as an effective standalone therapy. These findings, which build on earlier Phase 1 ALLCAR19 data, will be presented at the 2024 ASCO Annual Meeting in Chicago from May 31 through June 4, 2024.
Read Announcement
