Investing.com -- Shares in Bristol-Myers Squibb (NYSE:BMY) and 2seventy bio (NASDAQ:TSVT) fell in early trading on Monday after the pharma giant and its partner announced that U.S. health regulators will not meet a deadline next month to potentially approve earlier use of a blood cancer therapy.
Bristol Myers Squibb developed the drug, known as Abecma, with 2seventy bio as a treatment for adult patients suffering from multiple myeloma, a type of blood cancer that arises from plasma cells in bone marrow. The U.S. Food and Drug Administration (FDA) previously approved use of the treatment if four or more prior therapies did not lead to improvement in patients.
But the FDA told the companies that it will not be able to provide a decision on an application to introduce Abecma for earlier lines of treatment before its target date of Dec. 16, saying it will seek the advice of an independent committee of experts. The FDA added that it has not yet confirmed a date for a meeting of the panel, known as the Oncologic Drugs Advisory Committee (ODAC).
The application was based on the outcome of a late-stage trial that demonstrated Abecma "significantly" reduced the risk of disease progression or death versus "standard regimens" in patients with relapsed or refractory multiple myeloma.
Bristol Myers Squibb and 2seventy bio said in a statement that they "look forward to continuing discussions with the FDA and participating in the ODAC meeting."