- The FDA has granted accelerate approval AstraZeneca's Lynparza (olaparib) for the treatment of BRCA-associated advanced ovarian cancer. The move comes as a surprise considering that an FDA panel did not recommend the drug for expedited approval over the summer, citing a lack of sufficient data.
- In clinical studies, the objective response rate in Lynparza-treated women was 34% for an average 7.9 month period.
- Lynparza comes with a plasma-based companion diagnostic that detects BRCA mutations.
The approval of Lynparza not only heralds a new, improved era in the treatment of advanced ovarian cancer, but it also advances two trends that were evident in 2014—a focus on developing treatments that are more personalized and informed by genomics, as well as a trend towards the co-approval of treatments and their companion diagnostics.
Considering the fact that more than 14,000 women will die from ovarian cancer this year, the approval of Lynparza—and its companion diagnostic—bodes well for women looking for better treatment outcomes. And it bodes especially well for AstraZeneca, which is facing several major patent expirations in the coming years.