Dec. 23 Quick Takes: Lunsumio first bispecific for follicular lymphoma

FDA’s approval of Lunsumio mosunetuzumab-axgb from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) makes the CD20xCD3 T cell engager the first bispecific approved for relapsed or refractory follicular lymphoma. FDA’s Center for Drug Evaluation (CDER) has now approved 34 new molecular entities, down from 49 last year. Although it was a slow year for approvals by the agency, the drugs that were approved reflect a level of innovation across targets, modalities and indications unmatched by previous years.  

Ipsen Group (Euronext:IPN; Pink:IPSEY) said the complete response letter it received for palovarotene to prevent heterotopic ossification related to a prior FDA request for additional information regarding clinical trial data, and that it would respond next quarter. Ipsen resubmitted its NDA for the oral RARG agonist this year after withdrawing a prior submission in August 2021. The agency’s Endocrinologic and Metabolic Drugs Advisory Committee was set to discuss it on Oct. 31, but the meeting was postponed and has yet to be rescheduled. ...