The week in pharma: action, reaction and insight – week to March 10, 2023

By Barbara Obstoj-Cardwell. Editor

Among notable regulatory developments, last Thursday the US Food and Drug Administration (FDA) held an advisory committee (AdCom) meeting, for which briefing papers expressed concerns about the safety and efficacy of Swiss pharma giant Roche’s Polivy (polatuzumab), despite which the experts voted by 11 to 2 to recommend approval of the lymphoma drug in the first-line setting. Clinical research news included disappointing Phase III trial results from Incyte for Jakafi in myelofibrosis, which caused the company to discontinue the study. US drug developer Esperion released what it said were positive findings for its cardiac candidate Nexletol, but investors were not impressed, sending its stock lower. In comparison, US biotech BridgeBio Pharma scored a hit with investors, when it reported strong Phase II data on its infigratinib for the treatment of achondroplasia, or dwarfism. UK pharma major AstraZeneca released separate clinical results for two of its oncology drugs, Tagrisso and Imfinzi, in the treatment of lung cancer that impressed.

Polivy AdCom: no overall survival, no problem