Shire receives EU approval for Onivyde for pancreatic adenocarcinoma

Shire has announced that the European Commission has approved its cancer drug Onivyde as a treatment for metastatic adenocarcinoma of the pancreas.

The drug has been approved for use in combination with 5-fluorouracil and leucovorin in adult patients who have progressed following gemcitabine-based therapy, making it the first and only approved treatment option for this patient population.

Data from the phase III NAPOLI-1 study that demonstrated Onivyde was able to improve overall and progression-free survival rates, as well as objective response rates, compared to 5-fluorouracil and leucovorin alone.

In September 2015, the European Society of Medical Oncology indicated that Shire's drug, when available in all countries, may represent the best option for patients following gemcitabine-based therapy.

Dr Philip Vickers, global head of research and development at Shire, said: "The approval of Onivyde marks a significant step forward in Shire's focus to develop and commercialise treatments that represent the most promising science in oncology."

The drug was previously approved by the US Food and Drug Administration in October 2015.

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