Staff in regulatory affairs jobs at Roche have received a positive opinion on the approval of Tarceva as a treatment for a specific type of non-small cell lung cancer (NSCLC).
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a recommendation for the drug to be adopted as a first-line therapy for people affected by advanced epidermal growth factor receptor-activating mutation-positive NSCLC.
Tarceva is already approved in Europe for advanced or metastatic NSCLC irrespective of a patient's EGFR status as a maintenance treatment and for those whose condition has progressed after a course of chemotherapy.
However, data from clinical studies has shown that earlier administration of the drug could offer significant progression-free survival benefits.
Dr Hal Barron, chief medical officer and head of global product development at Roche, said: "The CHMP positive opinion for Tarceva is an important step in bringing a personalised medicine option to people with lung cancer."
According to financial data released by Roche this month, the company has seen successful outcomes from all seven of its late-stage clinical trials in the last six months.