FDA News

FDA grants Lynparza orphan drug designation for pancreatic cancer

The FDA granted orphan drug designation to olaparib for the treatment of patients with pancreatic cancer, according to the agent’s manufacturer.

Olaparib (Lynparza, AstraZeneca) is a first-in-class poly ADP-ribose polymerase inhibitor that may exploit DNA damage response pathway deficiencies to kill cancer cells.

“Pancreatic cancer is an area of significant unmet medical need,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued press release. “This is especially true for patients with metastatic disease, where the benefits of current treatment options are very limited.”

In the randomized phase 3 POLO trial, researchers are assessing olaparib among patients with BRCA-mutated metastatic pancreatic cancer who have not progressed following first-line platinum-based chemotherapy. Researchers randomly assigned 145 patients 3:2 to 300 mg olaparib twice daily or placebo.

Results are expected in 2019.

“Pancreatic cancer is a relatively less common, but life-threatening, form of cancer,” Roy Baynes, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in the release. “The FDA granting orphan drug designation is a positive step for patients with pancreatic cancer and continues to reinforce the importance of our collaboration in bringing Lynparza to more patients in need.”

Olaparib is indicated for the treatment of patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who were previously treated with chemotherapy; for the treatment of patients with BRCA-mutated, advanced ovarian cancer who have received three or more chemotherapy treatments; and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have completely or partially responded to chemotherapy.

The FDA granted orphan drug designation to olaparib for the treatment of patients with pancreatic cancer, according to the agent’s manufacturer.

Olaparib (Lynparza, AstraZeneca) is a first-in-class poly ADP-ribose polymerase inhibitor that may exploit DNA damage response pathway deficiencies to kill cancer cells.

“Pancreatic cancer is an area of significant unmet medical need,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued press release. “This is especially true for patients with metastatic disease, where the benefits of current treatment options are very limited.”

In the randomized phase 3 POLO trial, researchers are assessing olaparib among patients with BRCA-mutated metastatic pancreatic cancer who have not progressed following first-line platinum-based chemotherapy. Researchers randomly assigned 145 patients 3:2 to 300 mg olaparib twice daily or placebo.

Results are expected in 2019.

“Pancreatic cancer is a relatively less common, but life-threatening, form of cancer,” Roy Baynes, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in the release. “The FDA granting orphan drug designation is a positive step for patients with pancreatic cancer and continues to reinforce the importance of our collaboration in bringing Lynparza to more patients in need.”

Olaparib is indicated for the treatment of patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who were previously treated with chemotherapy; for the treatment of patients with BRCA-mutated, advanced ovarian cancer who have received three or more chemotherapy treatments; and for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have completely or partially responded to chemotherapy.