Roche cancer drug Tarceva set for first-line licence
pharmafile | July 25, 2011 | News story | Sales and Marketing | Cancer, Roche, Tarceva
Roche’s cancer drug Tarceva is on course to win a first-line indication in Europe for the first time after regulatory advisers backed its use in a form of lung cancer.
The CHMP issued a positive opinion on Tarceva (erlotinib) as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations.
The oral once-daily drug is currently licenced for either second-line treatment or maintenance therapy for metastatic non-small cell lung cancer, irrespective of EGFR status.
Hal Barron, Roche’s head of global product development, said: “The CHMP positive opinion for Tarceva is an important step in bringing a personalised medicine option to people with lung cancer.
“If approved for the treatment of lung cancer with EGFR activating mutations, Tarceva will offer patients with this type of advanced lung cancer a significant benefit when used as their first-line treatment.”
The use of Tarceva in people with EGFR-positive non-small cell lung cancer is supported by a number of studies, including two phase III trials that span both Western and Asian populations.
These studies showed that Tarceva significantly increased progression-free survival when compared to chemotherapy and indicate new potential for the difficult to treat disease.
Positive opinions from the CHMP usually translate into full European approval within three months and once Tarceva passes that point it will compete AstraZeneca’s Iressa, the current standard first-line treatment for NSCLC with EGFR mutations.
Ben Adams
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