Avastin Approved in Europe for First-line Treatment of Patients With Advanced Lung Cancer

First Medicine Shown to Extend Survival Beyond One Year in Previously Untreated Lung Cancer Patients

28-Aug-2007

Avastin (bevacizumab), Roche's anti-cancer drug, was approved in Europe for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy.

The approval is based on data from the pivotal US phase III trial (E4599) and the 'Avastin in Lung' (AVAiL) phase III trial. Both studies demonstrate that Avastin is effective for the treatment of patients with NSCLC in combination with platinum-based chemotherapy. The approval is for the use of Avastin at a dose of 7.5 or 15 mg/kg, in combination with platinum-based chemotherapy, for the first-line treatment of patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology. The broad label that Avastin has received for the treatment of NSCLC allows the combination of Avastin with any platinum-based chemotherapy regimens (for example, together with taxanes or gemcitabine) at the choice of the physician.

According to the company, Avastin is the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival for patients with colorectal, lung, breast and kidney cancer.

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