US FDA approves Pfizer’s blood cancer therapy

Aug 14 (Reuters) – The US Food and Drug Administration (FDA) on Monday granted accelerated approval to the (PFE.N) therapy to treat patients with a type of blood cancer that is difficult to treat, the company said.

The health regulator’s decision allows the use of the therapy, called Elrexfio, in patients with multiple myeloma that is difficult to treat or that 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, which help the body’s immune system kill cancer cells by uniting a cancer cell and an immune cell.

Elrexfio will be sold in the United States at a list price of $7,556 and $13,051 for the 44 mg and 76 mg vials, respectively, Pfizer said.

The therapy’s list price is expected to be $41,500 per month, the company said, adding that it expects the monthly price to be lower by around $26,000 as patients transition to bi-weekly dosing.

Pfizer has said the therapy could have more than $4 billion in maximum revenue potential.

The average duration of treatment for Elrexfio was eight months in the mid-stage trial, and the company expects the therapy to be available in the weeks following approval.

Multiple myeloma is a common type of blood cancer, which develops in the bone marrow and can spread throughout the body. Many patients see a relapse after stopping treatment, making this an area of ​​unmet need that drug manufacturers can tap into.

Other similar antibody therapies on the market include Roche’s (ROG.S) Columvi, Abbvie’s (ABBV.N) Epkins and Johnson & Johnson’s (JNJ.N) maybe what It was approved last week.

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 Monday.

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 to test 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 about neurological toxicity and cytokine release syndrome, a condition in which the immune system reacts more aggressively.

Reporting by Bhanvi Satija, Leroy Leo and Pratik Jain in Bengaluru; Edited by Shounak Dasgupta

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