Prospects for a fast-growing cancer drug developed by Roche were dented on Friday after the European Commission drug advisory panel decided not to back its approval in pancreatic cancer.
Tarceva (erlotinib) is already on the market for non-small cell lung cancer and achieved sales of 367 million Swiss francs in the first half of this year, only marginally short of its entire turnover for 2005. It was also cleared for pancreatic cancer by the US Food and Drug Administration last November.
The Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for Tarceva as a first line treatment, in combination with Eli Lilly’s Gemzar (gemcitabine) in patients with advanced pancreatic cancer, saying that beneficial effects on survival seen in clinical trials were ‘very limited’ and did not outweigh the increased side effect burden of the combination.
In addition, the panel said the Tarceva and gemcitabine regimen did not lead to any improvement in patient quality of life, and there were also only small improvements in progression-free survival and objective response rates.
In a statement, Roche said that it would ‘consider all options’ in the wake of the CHMP decision, including asking for the panel to re-examine the decision. It said both the US and European applications for approval were based on the same dataset – the PA3 study which showed that Tarceva and gemcitabine resulted in 22% longer survival than gemcitabine alone.
“Pancreatic cancer is one of the most aggressive forms of cancer and it kills more people within the first year of diagnosis than any other cancer,” said Eduard Holdener, head of global drug development at Roche. “Given such a poor outlook, even modest improvements in survival are valuable to advanced stage patients.”
Meanwhile, fellow Swiss drugmaker Novartis had better news when its Glivec (imatinib) cancer drug was backed by the CHMP for use in two new indications, namely acute lymphocblastic leukaemia and dermatofibrosarcoma protuberans.
Specifically, the CHMP recommended approval of Glivec for adult patients with newly diagnosed Philadelphia chromosome positive ALL integrated with chemotherapy, and also as a monotherapy in adult patients with relapsed or refractory Ph+ ALL. It also gave a go-ahead for use of the drug in adult patients with unresectable DFSP.
Glivec is already approved for chronic myeloid leukaemia and gastrointestinal stromal tumours and achieved sales of $1.2 billion in these indications in the first half of 2006.