Roche gains approval for pancreatic cancer treatment

Roche has announced that its novel cancer pharmaceutical, Tarceva (erlotinib), has been approved by the European Commission as a combination therapy with standard chemotherapy gemcitabine for the treatment of patients with metastatc pancreatic cancer.

Approval for the compound followed a phase III clinical trial showing that administration with Tarceva and gemcitabine in patients with metastatic disease resulted in 25 per cent longer survival compared to treatment solely with gemcitabine.

The trial also revealed that 21 per cent of patients were alive after a year of treatment with Tarceva plus gemcitabine, compared to 15 per cent of those administered only with gemcitabin, while patients receiving the combined treatment experienced 30 per cent progression-free survival.

Tarceva is a small molecule pharmaceutical that targets the EGFR, the human epidermal growth factor receptor (HER1) pathway to block the growth of tumour cell by inhibiting tyrosine kinase activity.

William M Burns, chief executive officer of Roche Pharmaceuticals, said: “The approval of Tarceva in combination with gemcitabine chemotherapy offers patients and their families some real hope.”

He added that this approval provided a “much-needed” advance in treatment for metastatic pancreatic cancer.

Last month, the Committee for Medicinal Products for Human Use awarded Tarceva a positive recommendation following a re-examination of data regarding the compound, following the receipt of a negative recommendation in July 2006.