- AstraZeneca
- 02 May 2023 09:52:17
Source: Sharecast
The FDA panel voted 11-1 with one abstention in favor of Lynparza, in combination with other medications – abiraterone and prednisone or prednisolone – as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients.
Astra’s experimental treatment was developed jointly with Merck & Co.
However, the panel recommended the approval to be limited only to patients whose tumors have a mutation in the BCRA genes, and advised against approval beyond this patient population.
The recommendation comes after Lynparza and similar class of therapies were hit by safety setbacks as clinical data suggested patients did not live as long as those given chemotherapy when administered as a second-line therapy.
Susan Galbraith, AstraZeneca’s executive vice-president of oncology research & development said: "Novel treatment options are urgently needed for patients with metastatic castration-resistant prostate cancer. While we are pleased with the recognition of the benefit of Lynparza plus abiraterone for patients with BRCA-mutated metastatic castration-resistant prostate cancer, we are disappointed with the outcome of today's ODAC meeting.”
“We strongly believe in the results of the PROpel trial, which demonstrated the clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status."
Reporting by Frank Prenesti for Sharecast.com
