The U.S. Food and Drug Administration approved Gilead Company Kite’s Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Bristol Myers Squibb reported that the company was abandoning the BCMA CAR-T therapy orva-cel and taking a $470 million write-off.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) for adults with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy.
Bristol Myers Squibb said the U.S. health regulator deferred a decision on an experimental blood cancer therapy that the company acquired in the $74 billion buyout of Celgene due to coronavirus-related travel restrictions.
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
Bristol-Myers Squibb Company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for lisocabtagene maraleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising individually formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after at least two prior therapies.