Amgen’s regulatory ambitions for its non-small cell lung cancer drug Lumakras (sotorasib) ran into headwinds Tuesday, after FDA staff indicated in their briefing document that there might not be sufficient evidence of its efficacy to justify full approval.
Tag Archive for: accelerated approval
The U.S. Food and Drug Administration’s staff reviewers said on Tuesday that Amgen’s late-stage study may not provide enough evidence of effectiveness for its lung cancer drug, as the company pursues a traditional approval for the treatment.
Topline data from the Phase III APPLAUSE-IgAN study showed that Novartis’ investigational complement inhibitor iptacopan met its pre-specified interim analysis primary endpoint, the company announced Monday.
Japan’s Takeda Pharmaceutical said on Monday it will voluntarily withdraw its lung cancer therapy from the United States, where it had received an accelerated approval in 2021, after it failed to meet the main goal in a late-stage study.
The health regulator’s decision allows use of the therapy, branded as Elrexfio, in patients with multiple myeloma that is hard to treat or has come back after receiving four or more prior lines of certain classes of treatments.
The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co. Ltd. and Biogen Inc.’s new Alzheimer’s drug Leqembi, should it win traditional U.S. approval as expected by July 6.
Last week, an FDA advisory committee gave Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) its unanimous blessing for traditional approval, signaling it will likely become the first drug of its class to receive this classification. While this is positive news for the biopharma partners and Alzheimer’s patients, concerns linger about the drug’s safety and Medicare coverage.
The FDA indicated it could potentially grant an accelerated approval for the therapy, called SRP-9001, initially for use in Duchenne patients aged 4 and 5.
Shares of Sarepta Therapeutics soared 29% premarket on Monday as a backing by the U.S. health regulator’s advisers increased the certainty of an accelerated approval for the company’s gene therapy for a muscle-wasting genetic disorder.
The U.S. Food and Drug Administration (FDA) plans to hold a meeting of its outside experts in June to discuss full approval of the Alzheimer’s drug developed by Eisai Co. Ltd. and Biogen Inc. according to a federal filing on Monday.
