Pfizer forges ahead with blood cancer therapy after approval from FDA

Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients.

The therapy has been granted accelerated approval for it’s specific use where multiple myeloma patients have previously received a minimum of four treatment lines, including use of a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This form of cancer, multiple myeloma, is a relatively common type of blood cancer, which initially develops in bone marrow and from there can spread throughout the body. Due to it’s capacity to spread easily through the body, patients who have been treated for the cancer often relapse when the initial treatment ceases. The recurrence of the cancer leaves patients open to undergoing several lines of treatment, prompting drug makers to address this ongoing issue. 

The administration of elranatamab lends it to being more patient centric as it is delivered subcutaneously. The treatment is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, and works by assisting the body’s natural immune system by bringing the cancer cell into proximity of an immune cell. 

10 Major Drug Approvals So Far in 2023

In this article we highlight 10 of the most recent novel drug approvals, covering a variety of fields of medicine, including migraines and menopause, to cancer drugs. Read the full article here >>> 

The efficacy and safety of the treatment was evaluated in the clinical trial MagnetisMM-3 (NCT04649359), an open-label, single-arm, multi-centre study, consisting of 97 patients. The study looked at the objective response rate and the duration of response in these patients. Finding the response rate for the recommended dose was 57.7% and the duration of response at 6 months was 90.4% and at 9 months it was 82.3%. 

Adverse side effects were seen in a large proportion of the test group, prompting the prescription information for elranatamab to come with a warning of life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity. 

Pfizer will be selling the branded Elrexfio at a list price of around $41,500 per month, which is expected to drop as patients progress into bi-weekly dosing regimens. They project the peak revenue for the treatment could reach more than $4 billion. 

Sources: Fierce Pharma. With FDA approval for Elrexfio, Pfizer brings multiple myeloma battle to Johnson & Johnson. [Date accessed 15/08/2023]. 

US Food and Drug Administration. FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma. [Date accessed 15/08/2023].