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 Takes $470 Million Write-off and Scraps Orva-Cel CAR-T Program
B-cell maturation antigen (BCMA), Biologics License Application (BLA), Bristol Myers Squibb, Business, CAR-T Therapy, Clinical Trials, PDUFA, R&D, Relapsed Or Refractory (R/R) Large B-Cell Lymphoma (LBCL), Therapeutics, Write-offsBristol 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.
FDA delays decision on Bristol Myers cancer therapy due to Covid-19 travel curbs
Acquisitions, Biologics License Application (BLA), Blood Cancers, Bristol Myers Squibb, Business, Coronavirus Restrictions, Facilities/Sites/Manufacturing, FDA, Investors, R&D, Relapsed Or Refractory (R/R) Large B-Cell Lymphoma (LBCL), TexasBristol 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.
FDA Action Alert: PTC and Roche, Lipocine, Incyte and Morphosys, and BMS
Adults, Babies, Children, Clinical Trials, Complete Response Letter, FDA, FDA/Regulatory, NDA Resubmission, New Drug Applications, PDUFA, Priority Review, R&D, Relapsed Or Refractory (R/R) Large B-Cell Lymphoma (LBCL), Spinal Muscular Atrophy (SMA), Survival motor neuron 1 (SMN1) gene, Survival Motor Neuron 2 (SMN2) GeneA 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.