Research & Development
AstraZeneca and Merck announce grant of Orphan Drug Designation by US FDA for pancreatic cancer medicine Lynparza
17 October 2018 -

Science-led biopharmaceutical company AstraZeneca Plc (LSE:AZ) and pharmaceutical company Merck & Co Inc (NYSE:MRK) (MSD outside the US and Canada) announced on Tuesday the grant of orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer.

Reportedly, ODD status was granted for the treatment of ovarian cancer in October 2013. Earlier this 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 are in a complete or partial response to platinum-based chemotherapy. This is the fourth Orphan Drug Designation in the US for AstraZeneca and MSD's Lynparza.

The FDA 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.

According to the companies, the use of Lynparza in pancreatic cancer is being assessed in the ongoing phase III POLO trial, which is testing Lynparza as maintenance monotherapy vs placebo in patients with germline BRCA-mutated metastatic pancreatic cancer, whose disease has not progressed following 1st-line platinum-based chemotherapy.

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

POLO is a phase III, randomised, double-blinded, placebo-controlled trial to In July 2017, AstraZeneca and Merck announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world's first PARP inhibitor and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types.

Under this collaboration, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.