NEW YORK, Aug. 14 (EFE) — The U.S. Food and Drug Administration (FDA) granted accelerated approval to Pfizer for Elrexfio, a subcutaneous therapy for patients with drug-resistant multiple myeloma, a type of An aggressive and hitherto incurable cancer of the blood.
Elrexfio is indicated for adult patients with multiple myeloma who have relapsed after at least four lines of certain therapies, the drugmaker said in a statement.
The FDA approved the therapy after studies showed “significant responses” in patients treated with it, Pfizer said.
It further indicated that study data showed that patients who had received four or more lines of other prior therapy achieved an overall response rate of 58% with Elrexfio, with an estimated 82% of patients maintaining remission for at least nine months.
Elrexfio therapy is “ready-to-use”, administered subcutaneously, and is a mature antigen of B cells (responsible for producing antigenic immunoglobulins, called antibodies) that help fight myeloma cells.
Multiple myeloma is an aggressive and currently incurable blood cancer that develops in the bone marrow.
“With the remarkable response in this patient population with highly refractory disease, we believe Elrexfio has the potential to become a new standard of care for multiple myeloma,” said Angela Hwang, chief commercial officer and president of the global biopharmaceutical business, in a statement. . Pfizer
The most common side effects of treatment with the drug were cytokine release syndrome, fatigue, injection site reactions, diarrhea, upper respiratory infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea and fever, the statement warned.
Multiple myeloma is the second most common type of blood cancer, with more than 35,000 new cases diagnosed each year in the United States and 176,000 new cases worldwide.