NEW YORK – AstraZeneca and Merck's olaparib (Lynparza) received approval on Thursday from China's National Medical Products Administration for newly diagnosed advanced ovarian cancer patients whose tumors have somatic or germline BRCA1/2 mutations.
The drug is intended to be used as a first-line maintenance treatment,which aims to prolong remission and reduce the risk of disease progression in this subset of patients.
China's approval is based on data from the Phase III SOLO-1 trial, which showed that olaparib reduced the risk of disease progression or death by 70 percent in the three-year time frame post-diagnosis. At the 36-month mark, the estimated progression-free survival rate for female patients treated with olaparib was 60 percent compared to 27 percent for patients on placebo.
Last year, the US Food and Drug Administration approved the same indication for olaparib. Myriad's diagnostic tool BRACAnalysis CDx was approved in tangent to help identify germline BRCA1/2 mutations. Earlier this year, the FDA also approved Foundation Medicine's companion diagnostic tool FoundationOne CDx, which can detect both germline and somatic BRCA1/2 mutations.
During the SOLO-1 trial, all patients had confirmed BRCA1/2 mutations determined via local or central testing. Ultimately, all detected germline BRCA1/2 mutations determined locally were confirmed at Myriad or at the Beijing Genomics Institute for study participants in China. BRCA1/2 mutations from tumor tissues were determined retrospectively by Foundation Medicine.
Olaparib is a PARP inhibitor, which generates an abundance of DNA damage that causes tumor cell death. This drug is the first PARP inhibitor approved in China for first-line maintenance in BRCAm advanced ovarian cancer.
"This approval marks a new era for women with BRCA-mutated advanced ovarian cancer in China, where the prevalence of BRCA mutations in advanced disease is higher than the international average," Dave Fredrickson, AstraZeneca's executive VP, said in a statement. "Currently, 70 percent of women relapse within three years of initial treatment, representing the highest reoccurrence rate among gynecological cancers worldwide."