The U.S. Food and Drug Administration issued Incyte Corporation with a Complete Response Letter (CRL) over the company’s Biologics License Application (BLA) for retifanlimab for anal cancer.
After the July 4 holiday, the U.S. Food and Drug Administration has several items on the regulatory agency’s immediate calendar, including a couple target action dates and an advisory committee hearing.
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of Biogen’s Alzheimer’s disease medicine Aduhelm (aducanumab), which has a list price of $56,000 per year.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration, voted 13-4 that a regulatory decision on Incyte’s PD-1 inhibitor retifanlimab for the treatment of advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) should be deferred until further data are available from the clinical trial POD1UM-303.
A third member of the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee resigned in protest over the regulatory agency’s approval of Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease.
Two members of a panel of outside advisors to the U.S. Food and Drug Administration resigned in protest at the regulatory agency’s decision to approve Biogen Inc.’s Aduhelm for the treatment of Alzheimer’s disease despite the committee’s recommendation against doing so.
Shares of Provention Bio Inc. plunged in trading after a Food and Drug Administration advisory committee narrowly supported the company’s diabetes prevention drug, teplizumab.
Merck announced positive results from the late-stage KEYNOTE-522 study for Keytruda as a neoadjuvant treatment for triple negative breast cancer, which should support the company’s previous attempt for U.S. approval that was stymied by a regulatory advisory committee in February and rejected by the Food and Drug Administration in March.
The U.S. Food and Drug Administration released a briefing document on May 4 citing concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. ChemoCentryx is seeking approval from the FDA for the drug as a therapeutic agent for anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (AAV).
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.