Roche appeals against negative CHMP ruling on Tarceva

Roche has said it has asked the European Committee for Medicinal Products for Human Use (CHMP) to re-examine the data submitted for Tarceva, after the committee returned a negative opinion on the use of the drug for patients with pancreatic cancer.

Although the CHMP itself does not hold any power to approve or reject drugs, its recommendations are hugely influential in the European Commission’s deliberations over new drug approval.

Roche points to the fact that the US FDA approved Tarceva for patients with locally advanced, unresectable or metastatic pancreatic cancer – a decision based on the same phase III study given to the CHMP, which showed that Tarceva combined with gemcitabine tablets results in a “significantly longer survival” time than patients given gemcitabine tablets alone.

In addition, nearly a quarter of Tarceva-plus-gemcitabine patients were alive after a year, compared to less than a fifth of patients on gemcitabine alone.

Eduard Holdener, head of global drug development at Roche, commented: “People with pancreatic cancer need new treatment options like Tarceva which has been proven in clinical trials to significantly increase survival and has already been approved for this indication in the US.”

“In light of this, we are asking the CHMP to re-consider its opinion,” he added.

Tarceva is designed to block cell growth in tumours by inhibiting the tyrosine kinase activity of the HER1 signalling pathway inside cancer cells.

The drug is currently used successfully in lung cancer, where an increased survival benefit of 42.5 per cent has been observed. Additional research into indications like ovarian, bronchioloalveolar, colorectal, brain and head and neck cancers, is continuing.

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