Olaparib New Indication for Prostate Cancer Submitted for Priority Review in China

Source: PharmaCube Info

On January 21, the CDE website indicated that AstraZeneca’s supplemental New Drug Application (sNDA) for olaparib tablets was proposed for inclusion in the priority review program. The new indication is for monotherapy in adult patients with metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 mutations (germline and/or somatic) who have experienced disease progression following prior treatment with novel hormonal agents.

The first oral poly(ADP-ribose) polymerase (PARP) inhibitor approved by the FDA, which kills tumor cells by inhibiting PARP enzyme activity and preventing PARP dissociation from DNA, thereby exploiting defects in DNA damage repair. It was first approved for marketing in the European Union and the United States in 2014.

According to the NextPharma database by PharmCube, olaparib generated revenues of $1.198 billion for AstraZeneca and $444 million for Merck & Co. in 2019.

Olaparib was first approved by the NMPA for marketing in August 2018. To date, it has been approved in China for the following indications: ① Maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy. ② First-line maintenance treatment for advanced ovarian cancer with BRCA mutations. ③ Maintenance treatment for advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer harboring BRCA mutations.