AstraZeneca and Merck announced that the Food and Drug Administration (FDA) has approved Lynparza (olaparib) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently voted in favor of the approval of Lynparza for this indication on December 17. The approval was based on data from the pivotal phase 3 POLO trial that included 154 patients with gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy. Patients were randomized 3:2 to receive Lynparza 300mg twice daily (n=92) or placebo (n=62) until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS), assessed by blinded independent central review using RECIST v1.1.
Results showed that Lynparza had a significantly longer median PFS compared with placebo (7.4 months vs 3.8 months; HR 0.53 [95% CI, 0.35-0.81]; P =.0035). An interim analysis of overall survival (secondary end point) demonstrated no difference between both groups based on 67% information fraction.
The safety and tolerability profile of Lynparza was consistent with that observed in previous clinical trials.
Hedy L. Kindler, Co-Principal Investigator of the POLO trial and Professor of Medicine, University of Chicago Medicine, said: “Today’s approval of olaparib based on the POLO results gives clinicians an important 1st-line maintenance treatment option which nearly doubled the progression-free survival benefit in patients with germline BRCA-mutated metastatic pancreatic cancer.”
Lynparza is already indicated for the first-line maintenance treatment of BRCA-mutated advanced ovarian cancer; maintenance treatment of recurrent ovarian cancer; advanced germline BRCA-mutated ovarian cancer after 3 or more lines of chemotherapy; and germline BRCA-mutated HER2-negative metastatic breast cancer.
The product is available as 100mg and 150mg tablets in 60- and 120-count bottles.
For more information visit lynparza.com.