Pfizer gets FDA accelerated approval for multiple myeloma treatment

 A Pfizer Inc. (PFE) treatment for relapsed or refractory multiple myeloma has received accelerated approval from the U.S. Food and Drug Administration, the pharmaceutical company said Monday. The treatment, Elrexfio, is a bispecific antibody for treatment of advanced multiple myeloma, a blood cancer that affects the plasma cells made in bone marrow. The treatment "provides a much-needed new option for heavily pre-treated multiple myeloma patients who are struggling with relapsed myeloma," clinical trial investigator Dr. Ajay Nooka, director of the multiple myeloma program at Emory University's Winship Cancer Institute, said in a statement. The FDA's accelerated approval program is designed to shorten review time for drugs that treat serious conditions and fill an unmet medical need. The Elrexfio label contains a boxed warning for neurologic toxicity and cytokine release syndrome, an aggressive immune-system response. Pfizer stock gained 0.5% Monday and is down 29% in the year to date, while the S&P 500 is up 16%.

https://www.morningstar.com/news/marketwatch/20230814296/pfizer-gets-fda-accelerated-approval-for-multiple-myeloma-treatment