Look back at pharma news in the week to April 2, 2021

Notable regulatory news last week included Bristol Myers Squibb and bluebird bio gaining US clearance for their Abecma, marking the first Food and Drug Administration approval for a CAR-T therapy in the treatment of multiple myeloma. Also, AbbVie had its new drug application for atogepant, a new migraine prevention candidate, accepted for review by the FDA. On the M&A front, Amgen announced last Wednesday that it is buying Rodeo Therapeutics and its 15-PGDH program in regenerative medicine. BioNTech and Pfizer presented more positive news on their COVID-19 vaccine BNT 162b2, this time on its efficacy in children, while Johnson & Johnson hit a production quality snag relating to its COVID-19 Vaccine Janssen.

FDA approves Abecma in r/r multiple myeloma as expected

On Friday, the US FDA approved Abecma (formerly idecabtagene vicleucel [ide-cel] or bb2121) as the first CAR-T cell therapy for relapsed or refractory multiple myeloma (r/r MM). Timing of the approval gives bluebird bio and Bristol Myers Squibb an around nine month lead versus competitors Johnson & Johnson and Legend Biotech, commented SVB Leerink Research analyst Dr Mani Foroohar. The label includes black boxed warnings (mostly as expected). To mitigate safety concerns, Abecma is available through a risk evaluation and mitigation strategy (REMS) that requires administration at a certified healthcare facility. Leerink updates its model to reflect approval (increasing PoS to 100%).