FDA advisory panel to assess broader application of Merck-AstraZeneca cancer medication

USA —Merck & Co Inc and AstraZeneca have announced that an independent committee of advisers to the U.S. Food and Drug Administration (FDA) will evaluate their application for the expanded use of their drug, Lynparza, to treat advanced prostate cancer.

The U.S. Food and Drug Administration’s committee is scheduled to convene on April 28th. The companies are seeking approval of the Lynparza drug in combination with abiraterone and prednisone or prednisolone to treat treatment-resistant prostate cancer in adult patients.

The application is based on data from a late-stage study that demonstrated the Lynparza combination improved overall survival compared to the placebo, in combination with abiraterone and prednisone/prednisolone, in patients who had not undergone prior chemotherapy.

At the ASCO Genitourinary Cancers Symposium (ASCO GU), it was revealed that the combination of Lynparza and Zytiga reduced the risk of progression or death by 34% compared to Zytiga alone, regardless of tumor mutation status.

Patients with homologous recombination repair (HRR) mutations experienced a greater benefit, with a 50% reduction in risk with the Lynparza regimen. In non-HRR mutation patients, the benefit was 24%.

Last year, Lynparza was authorized by the FDA as a treatment for early-stage breast cancer in patients with specific mutations.

The drug is also approved in the United States as a standalone treatment for another type of prostate cancer.

Prostate cancer is the most common form of cancer among men in the United States with an estimated 288,300 new cases in 2023, according to the American Cancer Society.

Merck has also halted a late-stage trial of Keytruda, its popular immunotherapy, for prostate cancer after interim data indicated it was unlikely to fulfill the primary objectives, marking the drugmaker’s third abandoned trial for the condition.

Last month, AstraZeneca and Merck presented final patient survival analysis for their PROpel trial, which showed a 19% reduction in the risk of death for patients receiving the Lynparza-Zytiga duo, though the improvement was not statistically significant.

Homologous recombination repair (HRR) mutated patients saw a wider 44% survival benefit, while non-HRR patients saw just an 11% reduction in death risk.

The FDA has been closely monitoring PARP inhibitors, including Lynparza, due to concerns about potential long-term harm to patients.

Last year, the FDA urged drugmakers to withdraw poly-ADP ribose polymerase (PARP) inhibitor approvals for late-line ovarian cancer and limited the use of Zejula to only cover patients with BRCA mutations.

Poly-ADP ribose polymerase helps damaged cells to repair themselves. As a cancer treatment, PARP inhibitors stop the PARP from doing its repair work in cancer cells and the cells die.

Clovis Oncology was hit hard by the FDA’s scrutiny, with the company filing for bankruptcy after withdrawing and limiting the uses of its only commercial product, Rubraca.

Despite the FDA’s request for more mature overall survival data, Clovis petitioned the agency to approve Rubraca as a first-line maintenance therapy, leading the FDA to threaten an advisory committee on the application.

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