FDA Panel Supports Narrow Lynparza Label for Prostate Cancer
BIOMARKER
1. The FDA's Oncologic Drugs Advisory Committee (ODAC) supported Merck’s and AstraZeneca’s PARP inhibitor Lynparza for a subset of metastatic castration-resistant prostate cancer (mCRPC) patients with a specific tumor mutation.
2. The ODAC voted 11-1, favoring Lynparza's risk-benefit profile in mCRPC patients with BRCA gene mutations.
3. Merck and AstraZeneca aim to expand Lynparza’s label to include all adult patients, regardless of mutation status.
4. The companies' sNDA showed a 34% decrease in the risk of radiographic progression or death after treatment with Lynparza in combination with Johnson & Johnson’s Zytiga and prednisone or prednisolone.
5. The survival benefit of Lynparza was significant compared to a placebo-based regimen.
6. Patients treated with Lynparza had a mean radiographic progression-free survival (rPFS) of 24.8 months, compared to 16.6 months for those on placebo.
7. The FDA extended the review period for Lynparza by three months in December 2022, requiring more time to evaluate the submission.
8. The FDA identified several issues with Lynparza’s sNDA, especially a "significant design flaw" in the Phase III PROpel study.
9. The FDA's post-hoc assessments showed that Lynparza's rPFS benefits were mostly due to its effects in patients with the BRCA mutation.
10. At the ODAC meeting, external experts agreed with the regulator’s staff, supporting a narrow approval for Lynparza.