The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for Lynparza (olaparib) to be used for the treatment of pancreatic cancer.
Pancreatic cancer is a rare and life-threatening disease that accounts for approximately 3% of all cancers in the US.
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Co-developed by AstraZeneca and Merck, Lynparza (olaparib) served as the first-in-class PARP inhibitor and the first targeted treatment that can potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCAmutations, to preferentially fight against cancer cells.
AstraZeneca chief medical officer and Global Medicines Development executive vice-president Sean Bohen said: “Pancreatic cancer is an area of significant unmet medical need. This is especially true for patients with metastatic disease where the benefits of current treatment options are very limited.”
Currently, the potential use of the drug for the treatment of pancreatic cancer is being studied in the on-going Phase III, randomised, double-blinded, placebo-controlled POLO trial.
The trial is evaluating the efficacy and safety of the Lynparza tablets (300mg twice daily) as maintenance monotherapy versus placebo in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following first-line platinum-based chemotherapy.
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By GlobalDataResults from the POLO trial are expected in the first half of next year.
MSD Research Laboratories chief medical officer and Global Clinical Development senior vice-president and head Roy Baynes said: “Pancreatic cancer is a relatively less common, but life-threatening, form of cancer.
“The FDA granting ODD 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.”
In July last year, AstraZeneca and Merck entered into global strategic oncology collaboration for the joint development commercialisation of the therapy.
