AstraZeneca and Merck get designation for Lynparza in pancreatic cancer

The FTSE 100 drugmaker and its US-based partner described pancreatic cancer as a rare, life-threatening disease that accounted for about 3% of all cancers in the United States

Due to the late onset of symptoms, patients were often diagnosed after the cancer had progressed to locally advanced or metastatic stages of the disease.

Five-year survival rates remained low in the US at 8.5%.

ODD status was granted for the treatment of ovarian cancer in October 2013.

Earlier in the year, an amended ODD status was granted to include both fallopian tube and primary peritoneal cancers following the expanded US approval of Lynparza in August 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who were in a complete or partial response to platinum-based chemotherapy.

The FDA reportedly grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

AstraZeneca said the use of Lynparza in pancreatic cancer was being assessed in the ongoing Phase III POLO trial, which was testing Lynparza as maintenance monotherapy compared to placebo in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease had not progressed following first-line platinum-based chemotherapy.

Results from the POLO trial were expected in the first half of 2019.

“Pancreatic cancer is an area of significant unmet medical need,” said AstraZeneca’s executive vice-president of global medicines development and chief medical officer Sean Bohen.

“This is especially true for patients with metastatic disease where the benefits of current treatment options are very limited.”

Roy Baynes, senior vice-president and head of global clinical development, and chief medical officer at Merck’s MSD Research Laboratories, added that pancreatic cancer was a relatively less common, but life-threatening, form of cancer.

“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,” Baynes explained.