Shire’s Onivyde recommended by EU regulators

Europe’s top scientific committee has recommended Shire’s Onivyde (irinotecan pegylated liposomal formulation) for advanced pancreatic cancer.

The Committee for Medicinal Products for Human Use’s (CHMP) positive opinion is for Onivyde’s use in metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin.

The recommendation paves the way for a European marketing authorisation in the coming weeks, in adults who have progressed following gemcitabine-based therapy.

Originally developed by Merrimack, Shire is responsible for development and marketing of the drug outside the US and Taiwan.

Merrimack markets Onivyde in the US after the US Food and Drug Administration approved it in October last year.

The drug could be a blockbuster for Shire, according to some analysts, and is already picking up sales in the US.

With a notoriously poor survival rate, there is an urgent need for new treatments for pancreatic cancer.

In England, patients will hope that Shire’s drug will be deemed as cost-effective by NICE, after a long-running saga around access to Celgene’s Abraxane (nab-paclitaxel).

Initially rejected by NICE, the drug was axed from the Cancer Drugs Fund late last year as part of a cost-saving drive.

Although Abraxane has a slightly different indication, as it is used as a first-line treatment, the lack of options for patients with the disease is a major cause for concern.

Survival rates are low as half of people diagnosed with the disease are already at stage 4 – the advanced metastatic disease stage which is considered incurable.

Five year overall survival rate is just 3% and median overall survival is typically less than a year.

The only curative treatment is surgical resection in the primary stage, which can improve five-year survival to 10%.

The CHMP positive opinion is based on pivotal, phase 3 NAPOLI-1 data that demonstrated the drug combination improved overall survival, meeting primary endpoint, as well as progression-free survival, and objective response rate (ORR) relative to the 5-fluorouracil and leucovorin control arm (secondary endpoints).

The most common grade 3 or higher adverse events with greater than five percent difference in patients on the Onivyde arm were neutropenia, fatigue and diarrhoea, and vomiting.

The CHMP’s decision will now be passed to the European Commission, which will likely approve the drug in the coming weeks.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.