Swiss drug major Roche and US partner OSI Pharmaceutical’s cancer drug Tarceva has moved a step closer to winning another approval in Europe after a green light for non-small cell lung cancer was recommended.
The European Committee for Medicinal Products for Human Use has given the thumbs up for Tarveca (erlotinib) for first-line maintenance of patients with locally-advanced or metastatic non-small cell lung cancer whose disease has not spread following first-line treatment with chemotherapy.
The positive opinion is based on data from the Phase III SATURN study, in which Tarceva, a once daily pill that is already on the market for pancreatic cancer and as a second-line therapy for lung cancer, was shown to significantly improve both progression-free survival and overall survival in patients with advanced NSCLC in the maintenance setting compared to placebo.
“Advanced lung cancer is an aggressive disease and when the cancer grows or spreads the health of patients deteriorates rapidly. By giving Tarceva earlier after chemotherapy, instead of waiting for the disease to progress, we could help more people live longer without their disease getting worse,” said Professor Federico Cappuzzo, Head of Oncology Unit, Livorno Hospital, Italy and principal investigator of the SATURN trial, explaining the drug’s promise in this indication.
Regulators across the pond are also currently reviewing Tarceva as a first-line maintenance therapy in advanced NSCLC, and are expected to make a decision by April 18, OSI said.
