The FDA has accepted the biologics license application for obecabtagene autoleucel for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.
The biologics license application (BLA) for obecabtagene autoleucel (obe-cel; AUTO1) for the treatment of adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (ALL) has been accepted by the FDA.
The FDA has issued a Prescription Drug User Fee Act (PDUFA) target action date of November 16, 2024.
There is currently no planned advisory committee meeting to discuss this application.
The FDA accepted the BLA submission for obe-cel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, in R/R B-cell ALL, according to Autolus Therapeutics.1 A PDUFA target action date of November 16, 2024, has been issued.
The review timeline is standard and consistent with recently approved CAR T-cell therapies, and the FDA has not announced any advisory committee meetings pertaining to this application so far.
“Acceptance of the BLA filing is an important milestone for Autolus and we look forward to continuing our collaboration with the FDA during the review cycle,” said Christian Itin, PhD, chief executive officer of Autolus, in a press release. “With the PDUFA date set for November, we remain focused on preparing for the potential launch of obe-cel.”
The submission and acceptance is based on findings from the phase 2 FELIX study (NCT04404660) presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023 and the American Society of Hematology (ASH) Annual Meeting in December 2023.
At ASCO, investigators presented frontline data showing that obe-cel delivered a 76% complete response (CR) rate or CR with incomplete count (CRi) rate.2
In updated findings presented at ASH, the CR/CRi rate was 77% (95/124), and the CR rate specifically was 57% (71/124).3 Among evaluable patients, 96% achieved minimal residual disease-negative status by central flow cytometry analysis. As of March 2023, the median duration of response had not yet been reached.
Regarding safety, only 2.4% of patients experienced grade 3 or greater cytokine release syndrome, while 7.1% of patients experienced grade 3 or greater immune effector cell-associated neurotoxicity syndrome.
Obe-cel was granted FDA orphan drug and regenerative medicine advanced therapy designations. Autolus also plans to submit a marketing authorization application for obe-cel for the same indication to the European Medicines Agency in the first half of 2024.1