Shire receives positive EU opinion for pancreatic cancer drug

pharmafile | July 25, 2016 | News story | Research and Development, Sales and Marketing CHMP, EU, Pancreatic cancer, Shire 

Shire has announced that the EU regulator’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorisation of Onivyde (irinotecan pegylated liposomal formulation) for the treatment of metastatic adenocarcinoma of the pancreas.

The treatment is recommended in combination with 5-fluorouracil and leucovorin in adult patients who have progressed following gemcitabine based therapy.

Pancreatic cancer is the third leading cause of cancer death across the EU, with limited treatment options available. Onivyde now has the potential to become a standard second-line therapy following gemcitabine-based therapy. It was approved by the FDA in the same indication last year.

The positive opinion adopted by the CHMP is based on the results of the Phase III NAPOLI-1 data that demonstrated improved overall survival and progression-free survival with Onivyde plus chemotherapy, compared to the two chemotherapy-based drugs alone.

Philip J. Vickers, head of R&D at Shire, says: “There has been little improvement in the prognosis for patients with metastatic pancreatic cancer in over 20 years. We therefore welcome the CHMP positive opinion for Onivyde, a regulatory milestone which brings us a step closer to helping patients with this devastating disease.”

A decision on whether or not to grant approval of the drug is expected from the European Commission later this year.

Sean Murray

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