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news.Roche has gained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the use of Tarceva in people with a genetically distinct type of non-small cell lung cancer (NSCLC), diagnosed with advanced EGFR (epidermal growth factor receptor) activating mutation positive NSCLC.
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Tarceva is a once-daily, oral, non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC.
The CHMP positive opinion is based on EURTAC study data that demonstrated Tarceva is superior to chemotherapy in EGFR activating mutation positive NSCLC.
Roche Global Product Development CMO and head Hal Barron said if approved for treatment of lung cancer with EGFR activating mutations, Tarceva will offer patients with this type of advanced lung cancer a benefit when used as their first line treatment.
The use of Tarceva in people with EGFR activating mutation positive advanced NSCLC has been supported by several studies including two Phase III trials conducted in Western and Asian populations.
Tarceva is already approved in Europe for use in advanced or metastatic NSCLC.