FDA grants accelerated approval to Pfizer’s therapy for the treatment of a challenging form of blood cancer

Pfizer has announced on Monday that the US Food and Drug Administration (FDA) has granted expedited approval to their treatment for a challenging form of blood cancer.

This decision, as reported by Reuters, is based on compelling data from a mid-stage study, which indicated that a significant portion of patients undergoing Pfizer’s therapy displayed either a complete absence of cancer or a substantial reduction in cancer cells.

This landmark ruling allows the application of Pfizer’s treatment named ‘Elrexfio’ to patients dealing with multiple myeloma, a form of blood cancer that often proves resistant to conventional treatments and tends to reappear even after a patient has undergone four or more rounds of specific types of therapies, according to Reuters.

The medication, administered subcutaneously (under the skin), is also known as elranatamab, and falls under the category of bi-specific antibodies. These antibodies enhance the immune system’s capacity to identify and eliminate cancerous cells by connecting immune cells with cancer cells.

In the United States, Pfizer has priced the therapy at $7,556 for the 44 mg vial and $13,051 for the 76 mg vial.

The initial list price of the therapy, according to Pfizer, is projected to be roughly $41,500 per month. However, the company foresees the monthly expense dropping to approximately $26,000 as patients transition to bi-weekly dosing.

Based on the results of the mid-stage trial, Elrexfio’s typical treatment duration spans eight months. According to Pfizer, the therapy is expected to become available to patients in the weeks following FDA approval.

Multiple myeloma, a prevalent blood cancer type originating in the bone marrow, can spread throughout the body. Recurrence of the disease often occurs once treatment is discontinued, and Elrexfio aims to address this unmet medical necessity.

Existing antibody therapies on the market encompass Roche’s Columvi, Abbvie’s Epkinly, and Johnson & Johnson’s recently sanctioned Talvey.

A distinctive feature of Elrexfio lies in its potential for “off-the-shelf” use. Healthcare providers in hospitals and clinics can continually administer the treatment, enhancing accessibility for patients, Pfizer noted.

It’s noteworthy that the approval of this therapy comes with a boxed warning associated with neurologic toxicity and cytokine release syndrome, a condition marked by an intensified immune system response.