The United States Food and Drug Administration granted on 14 August accelerated approval to Pfizer's Elrexfio, a drug designed to treat patients with a hard to combat type of blood cancer.
The health regulator said in a press release that its decision allows use of the Elrexfio therapy in patients with multiple myeloma, which is difficult to treat or comes back after multiple lines of certain classes of treatments.
Multiple myeloma is a common type of blood cancer, which develops in the bone marrow and can spread throughout the body. Unlike leukemia, myeloma cells do not usually circulate in the blood stream, but stay in the bone marrow.
Elrexfio, which is the commercial name of “elranatamab,” is administered under the skin and belongs to a class of therapies known as bispecific antibodies, which are engineered to help the body's immune system to kill cancerous cells by bringing a cancer cell and an immune cell together, the company explained in a statement.
Data from a mid-stage study 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.
The therapy's approval comes with warnings for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively.
Elrexfio can be used "off-the-shelf" and can be delivered on an ongoing basis by healthcare providers in hospitals and clinics.
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Pfizer expects its therapy to generate more than 4 billion dollars in revenue. At a 41,500-dollar average monthly list price, a typical Elrexfio treatment course will cost about 330,000 dollars based on the duration of therapy reported during clinical testing.
Pfizer is not the only drugmaker for myeloma patients. Its main competitor, Johnson & Johnson earned FDA approval for its Talvey a week ago, amid the presence of Roche's Columvi and Abbvie's Epkinly in the market.
Pfizer will continue testing the therapy in ongoing late-stage trials.
In spite of Elrexfio’s above the average efficiency, the International Myeloma Foundation welcomed the FDA’s approval for Pfizer.
With headquarters in New York City, Pfizer posted a revenue of more than 100 billion dollars in 2022, while the profit amounted to over 31 billion dollars the same year.