Roche’s Tarceva Receives European Approval

Roche announced today that the European Commission has approved Tarceva for use in patients with a genetically distinct type of non-small cell lung cancer in Europe.  This approval will enable the use of Tarceva as a first-line monotherapy in people with locally advanced or metastatic non-small lung cancer with EGFR (epidermal growth factor receptor) activating mutations.

Tumours with these mutations are responsive to Tarceva and treatment with this medicine has been shown to more than triple the number of patients whose tumours shrink (response rate).  Tarceva has also shown to nearly double the time patients live without their disease progressing (progression free survival – PFS) compared to chemotherapy.

Hal Barron M.D., Chief Medical Officer and Head, Global Product Development commented that “the European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment”.  “Advanced lung cancer is often diagnosed with little warning of symptoms and progresses aggressively so it is important to identify which patients may benefit from early treatment with Tarceva.”

Lung cancer is the leading cause of cancer death globally, killing more people than breast, colon, kidney, liver, skin and prostate cancers combined.   In 2008, there were 1.6 million new cases of lung cancer and 1.3 million people die as a result of the disease every year.  It is estimated that 10%-30% of patients with non-small cell lung cancer have tumours with epidermal growth factor receptor activating mutations.  Roche Molecular Systems is developing the cobas epidermal growth factor receptor mutation test, a companion diagnostic for Tarceva, to identify patients with epidermal growth factor receptor mutations.   The CE Mark for this test is expected for the second half of 2011.

Tarceva is already approved in Europe for use in advanced or metastatic non-small cell lung cancer irrespective of a patient’s epidermal growth factor receptor status, both as maintenance therapy in patients with stable disease immediately after initial chemotherapy, and in patients whose disease has progressed following at least one course of chemotherapy.


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