Despite questionable PARP data, FDA stamps quick OK on Lynparza as a frontline therapy for pancreatic cancer
FDA analysts picked apart the data, highlighted an absence of overall survival benefit and noted that AstraZeneca had yet to hit the mark required for earlier pancreatic cancer drug approvals — but it didn’t make any difference in the end. Shortly after a slight majority of expert advisers voted 7 to 5 in favor of using Lynparza as a maintenance therapy for germline BRCA-mutated metastatic adenocarcinoma of the pancreas after 16 weeks of dormancy, the FDA followed up with a formal sanction of its own on Monday.
The move further solidifies the leading position AstraZeneca and Merck hold in the PARP field as Lynparza continues to rack up new successes in oncology. This new OK follows landmark approvals in ovarian and breast cancer as the major league partners line up new fields to conquer with a drug that targets a repair pathway for cells.
The regulatory bar is set particularly low in oncology, and that’s especially true for hard-to-treat cases like pancreatic cancer, where survival benefits are low. The approval was largely based on data indicating a longer span of progression-free survival for patients, though regulators noted issues with the trial used to gain the OK. But Lynparza is well known to the FDA, making it easier to take a flyer on it.
Dave Fredrickson, AstraZeneca’s EVP of the oncology business unit, said:
Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades. Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer.