Melphalan Flufenamide

The FDA announced its final decision to rescind approval of melphalan flufenamide, citing safety concerns.

The manufacturer of a drug that received FDA approval earlier this year for treatment of multiple myeloma has pulled the therapy from the U.S. market.

The FDA alerted health care providers and patients about clinical trial results that showed increased mortality risk among patients with multiple myeloma treated with melphalan flufenamide.

Maung Myo Htut, MD, associate clinical professor in the division of multiple myeloma within the department of hematology and hematopietic cell transplantation at City of Hope, discussed treatment developments in multiple myeloma, including exciting data from ASH 2020, the role of CAR T-cell therapy, autologous hematopoietic stem cell transplant, consolidation therapy and more.

The FDA granted accelerated approval to melphalan flufenamide in combination with dexamethasone for treatment of certain patients with relapsed or refractory multiple myeloma.

The FDA has made several notable approvals and decisions on treatment for multiple myeloma in the past year. To highlight new and emerging therapies, Healio compiled a list of these potentially practice-changing FDA actions.