Atara Biotherapeutics Reports the US FDA’s BLA Acceptance with Priority Review of Tabelecleucel to Treat Post-Transplant Lymphoproliferative Disease
Shots:
- The US FDA has accepted & granted priority review (PDUFA: Jan 15, 2025) to the BLA of tabelecleucel (tab-cel) alone to treat adults & pediatrics (≥2yrs.) with EBV+ post-transplant lymphoproliferative disease. Pierre Fabre & Atara anticipate the US launch in early 2025
- The BLA was based on the data from studies involving >430 patients, incl. ALLELE trial, showing ORR of 48.8% with a favorable & consistent safety profile
- Atara will get a $20M milestone for BLA acceptance from Pierre Fabre with another $60M on FDA approval plus sales milestones & double-digit tiered royalties across the US & international markets. Pierre Fabre will reimburse the global development costs via the BLA transfer & purchasing tab-cel inventory through the manufacturing transfer date
Ref: Atara Biotherapeutics | Image: Atara Biotherapeutics
Related Posts:- Atara Biotherapeutics Ebvallo (tabelecleucel) Receives EC’s Approval for Epstein‑Barr Virus Positive Post‑Transplant Lymphoproliferative Disease
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
