Accelerated approval has been granted to a new therapy from Pfizer for a specific type of blood cancer that is difficult to treat, said the US Food and Drug Administration this week.
Reuters reports that the decision allows use of the therapy, branded as Elrexfio, in patients with multiple myeloma that is hard to treat or has come back after four or more prior lines of certain classes of treatments.
Elrexfio, or elranatamab, is administered under the skin and belongs to a class of therapies known as bispecific antibodies, which help the body’s immune system to kill cancerous cells by bringing a cancer cell and an immune cell together.
The list price of the therapy is expected to be $41 500 per month, the company said, but it expects the monthly price to be lower at about $26 000 as patients move to bi-weekly dosing.
Elrexfio’s average treatment duration was eight months in the mid-stage trial, and the company expects the therapy to be available in the weeks after approval.
Multiple myeloma is a common blood cancer that develops in the bone marrow and can spread throughout the body. Several patients see a relapse after stopping treatment, making it an area of unmet need into which drugmakers can tap.
Other similar antibody therapies in the market include Roche’s Columvi, Abbvie’s Epkinly and Johnson & Johnson’s Talvey, which was approved last week.
The FDA approval is based on data from a mid-stage study showing that 58% of patients treated with Pfizer’s therapy had no signs of cancer or had seen a significant decrease in cancer cells in the body.
The therapy’s approval comes with a warning for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively.
Reuters article – US FDA approves Pfizer’s blood cancer therapy (Open access)
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