Lynparza Receives New Pancreatic Cancer Indication

December 31, 2019 – The U.S. FDA has approved a new indication for Lynparza® (olaparib), manufactured by AstraZeneca Pharmaceuticals. The product is now indicated to provide first-line maintenance treatment for patients who have deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma and whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy. Patients should be selected for treatment based on the results of an FDA-approved diagnostic test.

Approximately 95% of patients with pancreatic cancer have pancreatic adenocarcinoma. This type of pancreatic cancer occurs when the pancreas’s exocrine cells, which produce enzymes needed to digest food, grow out of control. Overall, pancreatic cancer has a poor five-year survival rate, with estimates for metastatic disease as low as 3% according to the American Cancer Society. Lynparza is thought to help treat gBRCAm metastatic pancreatic adenocarcinoma by interfering with an enzyme called PARP on which the cancer cells rely to repair damage to their DNA.

In a clinical trial, Lynparza delivered an overall response rate of 23% compared to 12% with placebo in patients who had measurable disease at baseline. Median overall survival with Lynparza was 18.9 months compared to 18.1 months with placebo, while the drug delivered a median progression-free survival time of 7.4 months compared to 3.8 months with placebo. Recommended dosing is 300mg taken by mouth twice daily, with or without food. Patients should continue treatment until disease progression or unacceptable toxicity occurs.

First FDA approved in 2014, Lynparza is also indicated to treat breast cancer and ovarian cancer in certain patient populations.