FDA Panel Backs Restricted Use Of AztraZeneca And Merck’s Prostate Cancer Treatment

FDA advisers endorse limited use of AztraZeneca and Merck’s experimental prostate cancer treatment, Lynparza, in combination with other medications

In an important development, the advisory panel of the U.S. Food and Drug Administration (FDA) has given a green light to the restricted use of an experimental prostate cancer treatment developed jointly by AztraZeneca Plc, a British pharmaceutical company, and Merck & Co.

The panel’s decision came in favor of the treatment named Lynparza, by a vote of 11-1 with one member abstaining. The vote supported the use of Lynparza in combination with other medications, namely abiraterone and either prednisone or prednisolone, as an initial treatment for a certain kind of treatment-resistant prostate cancer in adult patients.

However, the panel did not endorse the use of this therapy beyond this specific patient group. The decision follows a series of safety concerns regarding Lynparza and similar therapies, as the data indicated patients didn’t live as long as those undergoing chemotherapy when given as secondary treatment.

The treatment in question, Lynparza, is a PARP inhibitor, a class of drugs that also includes medications from Clovis Oncology and GSK Plc. These drugs faced a setback last year when they were withdrawn as a secondary treatment for ovarian cancer patients after the FDA restricted the use of PARP inhibitors.

This recent endorsement of Lynparza is based on the results of a late-stage study. The study revealed that the combination of Lynparza and other medications significantly extended the period of time patients lived without the disease progressing, compared to the placebo combined with abiraterone and prednisone/prednisolone.

Lynparza has already received FDA approval for the treatment of a certain type of breast cancer, ovarian cancer, and a different variant of prostate cancer.

Prostate cancer is the most prevalent cancer among men in the U.S., with approximately 288,300 new cases predicted in 2023 as per the American Cancer Society. Although the FDA generally follows the recommendations of its advisory panel, it is not obliged to, and will make the final decision regarding the use of Lynparza.

Written by Muhammad Qasim