The European Medicines Agency has done a U-turn and voted to to recommend Roche’s Tarceva as a treatment for pancreatic cancer, after re-evaluating the data.
The recommendation, which comes from the agency's Committee for Medicinal Products for Human Use (CHMP), reverses its decision to reject Tarveva (erlotinib) in combination with gemcitabine as a first-line therapy for pancreatic cancer in July.
Roche asked the CHMP to look again at the data in September, noting that Tarceva, which is approved for non-small cell lung cancer in Europe, had been given the green light by the US Food and Drug Administration for pancreatic cancer in November using the same data set as had been filed in Europe. The CHMP has now agreed with its US counterpart and its recommendation is expected to be endorsed by the European Commission within 45 days.
Eduard Holdener, head of global drug development at the Swiss firm, said that "news of the CHMP opinion will be welcomed by pancreatic cancer patients across the EU as it widens previously limited treatment options."
Roche sells the drug in Europe and Genentech markets it in the USA, while OSI Pharmaceuticals receives royalties from Tarceva sales. It is, however, seen in some countries as a pricey product, and in the UK recently, the National Institute for Health and Clinical Excellence decided not to support the prescribing of the drug for lung cancer on the National Health Service.
Mircera review extended
There was disappointing regulatory news from across the Atlantic, however, as Roche revealed that the US Food and Drug Administration has extended its review period for the group's anaemia drug Mircera (continuous erythropoietin receptor activator) for patients with chronic kidney disease by three months.
The Swiss drugmaker has submitted additional data to the FDA in support of its Biologic Licence Application for Mircera, which Mr Holdener said will help to give the FDA "additional clarity in key areas" that it is monitoring with already available anti-anaemia agents.