The National Medical Products Administration (NMPA) in China has granted AstraZeneca (AZ, NASDAQ: AZN) and Merck, Sharp & Dohme (MSD; NYSE: MRK) a regulatory nod for their drug Lynparza (olaparib). The approval is for adjuvant treatment in adult patients with early high-risk breast cancer who have undergone neoadjuvant or adjuvant chemotherapy and carry harmful or suspected harmful germline BRCA mutations (gBRCAm), and are negative for human epidermal growth factor receptor 2 (HER2). This decision is based on the positive results from the Phase III OlumpiA study.
Lynparza’s Expanding Role in Cancer Treatment in China
Lynparza, a PARP inhibitor, was first approved in China in August 2018 for the treatment of various cancers, including epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and prostate cancer. The drug’s approval for early high-risk breast cancer further expands its role in the country’s cancer treatment landscape.
Joint Development and Commercialization Efforts by AZ and MSD
AstraZeneca and Merck & Co. entered into a partnership in July 2017 to jointly develop and commercialize Lynparza and other oncology products, either as monotherapy or in combination with other drugs. Concurrently, both companies independently develop these products in combination with their respective PD-L1 and PD-1 inhibitors, showcasing a collaborative approach to advancing cancer treatments.-Fineline Info & Tech
