AstraZeneca, Merck & Co.'s Lynparza gains FDA approval as maintenance treatment for HRD-positive advanced ovarian cancer

AstraZeneca and Merck & Co. said that the FDA approved Lynparza (olaparib) in combination with Roche's Avastin (bevacizumab) for the maintenance treatment of certain adults with homologous recombination deficiency (HRD)-positive advanced ovarian cancer. Specifically, the PARP inhibitor is indicated for use in adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with HRD-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

According to the companies, the approval is based on data from the Phase III PAOLA-1 trial, which showed that Lynparza in combination with Avastin maintenance treatment reduced the risk of disease progression or death by 67%. Results demonstrated that the addition of Lynparza improved progression-free survival to a median of 37.2 months versus 17.7 months with Avastin alone in patients with HRD-positive advanced ovarian cancer.

Dave Fredrickson, executive vice president of AstraZeneca's oncology unit, remarked "the median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease." The executive added "these results further establish that HRD-positive is a distinct subset of ovarian cancer, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer."

AstraZeneca and Merck noted that patients will be selected for therapy based on an FDA-approved companion diagnostic, with Myriad Genetics' myChoice CDx test gaining US clearance alongside Lynparza in this indication. Meanwhile, regulatory reviews are currently under way in the EU, Japan and other countries for the drug based on results from the PAOLA-1 trial.

Lynparza, which is also approved in various other settings in ovarian cancer, as well as certain patients with metastatic breast cancer and pancreatic cancer, generated sales of $397 million in the first quarter, up 67% year-over-year. Last month, AstraZeneca and Merck announced that the drug significantly improved overall survival versus new hormonal agent treatments in men with metastatic castration-resistant prostate cancer (mCRPC) selected for BRCA1/2 or ATM gene mutations.

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