Roche’s Avastin gets positive opinion from EMA as second-line colorectal cancer treatment

Hannah Blake

pharmaphorum

The European Medicines Agency has granted a positive opinion for the additional data of Roche’s Avastin treatment beyond first progression in patients with advanced colorectal cancer.

The EMA based their opinion on additional data provided from the ML18147 clinical study on the current European label of Avastin (bevacizumab), which demonstrated that patients with metastatic colorectal cancer who were initially treated with Avastin, lived longer when they continued on Avastin-based therapy after their disease had progressed for the first time, than those who received only chemotherapy after disease progression.

Therefore, the EMA’s decision will allow patients diagnosed with metastatic colorectal cancer, that receive Avastin plus chemotherapy as a first line treatment, to continue to receive Avastin plus chemotherapy as a second line treatment after their cancer worsens.

"People with metastatic colorectal cancer who continued Avastin treatment with a new chemotherapy regimen after their cancer worsened lived longer than patients who changed to a new chemotherapy only. This positive CHMP opinion is an important step towards potentially changing the approach to treatment of metastatic colorectal cancer and providing a new option for patients.”

Hal Barron M.D., Roche’s Chief Medical Officer and Head of Global Product Development.

Avastin is the only biological therapy proven to increase overall survival when used first-line, beyond first progression, and in second-line treatment of metastatic colorectal cancer.

Over 1.2 million new cases of colorectal cancer are diagnosed each year, making it one of the most common cancers in the world.

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