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The health regulator’s decision allows use of the therapy, branded as Elrexfio, in patients with multiple myeloma that is hard to treat or has come back after receiving 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, that helps the body’s immune system to kill cancerous cells by bringing a cancer cell and an immune cell together.
Pfizer has said the therapy could have more than $4 billion in potential peak revenue.
Multiple myeloma is a common type of blood cancer, which 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 that drugmakers can tap into.
Other similar antibody therapies in the market include Roche’s Columvi, Abbvie’s Epkinly and Johnson & Johnson (NYSE:JNJ)’s Talvey, which was approved last week.
Pfizer’s Elrexfio can be used “off-the-shelf” and can be delivered on an ongoing basis by healthcare providers in hospitals and clinics, the company said on Monday.
The company did not immediately respond to a request for comment on the therapy’s price and availability.
The FDA approval is based on data from a mid-stage study that showed 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.
Pfizer said it will continue testing the therapy in ongoing late-stage trials to expand its use in earlier lines of treatment for patients.
The therapy’s approval comes with a boxed warning for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively.
