Pfizer’s therapy for a challenging type of blood cancer has gained accelerated approval from the U.S. Food and Drug Administration (FDA), the pharmaceutical company announced on Monday.
The FDA’s decision permits the use of the therapy, known as Elrexfio, in patients grappling with multiple myeloma that is resistant to treatment or has relapsed after undergoing four or more prior rounds of specific classes of treatments.
Administered subcutaneously, Elrexfio, also called elranatamab, falls within the category of bispecific antibodies. This innovative treatment approach facilitates the body’s immune system in targeting cancerous cells by bringing together a cancer cell and an immune cell.
Pfizer stated that Elrexfio will be available in the U.S. at a list price of $7,556 for the 44 mg vial and $13,051 for the 76 mg vial. The company projected the therapy’s monthly price to be about $41,500 initially, but as patients transition to bi-weekly dosing, this monthly cost is expected to decrease to around $26,000.
Pfizer has estimated that the therapy could generate over $4 billion in potential peak revenue.
In mid-stage trials, the average treatment duration for Elrexfio was eight months. The company anticipates that the therapy will be accessible in the weeks following the FDA’s approval.
Multiple myeloma, a prevalent form of blood cancer that originates in the bone marrow and can spread throughout the body, often leads to relapses after treatment cessation. This unmet need in the medical field presents an opportunity for pharmaceutical companies.
Similar antibody therapies available in the market include Roche’s Columvi, Abbvie’s Epkinly, and Johnson & Johnson’s Talvey, which secured approval last week.
Elrexfio can be conveniently used “off-the-shelf” and administered continuously by healthcare professionals in medical facilities, Pfizer noted.
The FDA’s approval is grounded in data from a mid-stage study revealing that 58% of patients treated with Pfizer’s therapy exhibited no signs of cancer or experienced a substantial reduction in cancer cells within the body.
Pfizer confirmed that it will further assess the therapy through ongoing late-stage trials to expand its application to earlier stages of treatment.
The approval of this therapy comes with a boxed warning for neurologic toxicity and cytokine release syndrome, an immune system response that can be overly aggressive.
