DREN BIO, INC. | MedPath

Autolus Therapeutics' AUCATZYL® (obecabtagene autoleucel) Receives FDA Approval for Adult B-cell ALL

6 months ago

• Autolus Therapeutics' AUCATZYL® (obecabtagene autoleucel) has been approved by the FDA for treating adult B-cell Acute Lymphoblastic Leukemia (B-ALL). • The FDA approval triggers a $30 million milestone payment from Blackstone, enhancing Autolus' financial position. • Autolus reported a strong cash position of $657.1 million in Q3 2024, supporting the commercial launch of obecabtagene autoleucel. • Marketing authorizations for obecabtagene autoleucel are under review with both the MHRA and EMA, potentially expanding its availability.

Autolus Therapeutics' AUCATZYL® Launch On Track After FDA Approval

6 months ago

• Autolus Therapeutics is progressing with the commercial launch of AUCATZYL® for adult relapsed/refractory B-cell acute lymphoblastic leukemia. • Twenty-four treatment centers are fully authorized as of January 10th, supporting access to this novel CAR-T therapy for patients. • The National Comprehensive Cancer Network® has included AUCATZYL® in its Clinical Practice Guidelines in Oncology. • Autolus plans to share clinical development program updates, including expansion into autoimmune diseases, at an April 23rd R&D event.