UK-based AstraZeneca (NASDAQ: AZN) and US-based Merck, Sharp & Dohme (MSD, NYSE: MRK) have announced that they have received another indication approval from the National Medical Products Administration (NMPA) for Lynparza (olaparib). The poly (ADP-ribose) polymerase (PARP) inhibitor is now approved as a maintenance therapy for homologous recombination repair deficiency (HRD)-positive advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. These cancers must have achieved complete or partial remission after first-line treatment with platinum-containing chemotherapy combined with bevacizumab. The approval is based on the results of the pivotal Phase III PAOLA-1 study.
Previous Approvals and Market Presence
Lynparza was the first PARP inhibitor to gain market approval in China in August 2018, initially indicated for direct therapy in platinum-sensitive ovarian cancer. In December 2019, the drug, which was included on the National Reimbursement Drug List (NRDL) a month earlier, received approval as a first-line maintenance treatment for BRCA-mutated advanced ovarian cancer. The drug subsequently gained a third market approval in June of last year for treating metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutation (germline and/or somatic cell line) and disease progression after previous treatment with new hormone therapies.
Future Outlook and Reimbursement Status
Last week, Lynparza passed the formal review stage for inclusion in this year’s NRDL update process, indicating that the drug may enjoy further expanded coverage. This fourth approval in China underscores the drug’s continued expansion and its potential to address significant unmet needs in the treatment of HRD-positive cancers.-Fineline Info & Tech
