FDA hands Pfizer accelerated approval for myeloma therapy

The FDA has granted accelerated approval to Pfizer's drug Elrexfio, which is intended to treat patients who have experienced relapsed or refractory multiple myeloma, a presently incurable type of blood cancer, according to an Aug. 14 news release. 

"With the approval of Elrexfio, patients have a new off-the-shelf treatment option that can be delivered on an ongoing basis in community clinics, where the majority of patients with multiple myeloma receive their care," Jenny Ahlstrom, CEO of the HealthTree Foundation for Multiple Myeloma, said in the release.

Elrexfio — also known as elranatamab-bcmm — works by activating T-cells to kill myeloma cells. In clinical trials, the drug showed positive response rates in 58 percent of patients who received four or more lines of therapy before receiving the drug. Of the 58 percent who responded well, 82 percent maintained the positive results for at least nine months, according to the release.

"We advanced this therapy from a first-in-patient trial to approval in less than five years, because we know that time is life for people living with multiple myeloma," Angela Hwang, chief commercial officer and president of global biopharmaceuticals business at Pfizer said in the release. "With significant responses in a patient population with highly refractory disease, we believe Elrexfio is poised to potentially become the new standard of care for multiple myeloma…"

Ms. Hwang noted in the release that Pfizer will continue to work on expanding the extensive MagnetisMM clinical development program.

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