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Roche: EU approval in lung cancer

( - The European Commission authorizes Roche's Alecensa as the first and only targeted adjuvant therapy for people with early-stage ALK-positive lung cancer.

Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with resected ALK-positive non-small cell lung cancer, as demonstrated by the ALINA phase III trial.

The approval of Alecensa addresses an urgent unmet need at an early stage, where around half of people experience disease recurrence after surgery, despite adjuvant chemotherapy.

Early diagnosis and treatment of lung cancer can reduce the burden associated with disease progression, and give patients the best possible chance of a cure.

For the first time, people in Europe who have undergone surgical resection of ALK-positive NSCLC can be treated with an ALK inhibitor, which can significantly reduce the risk of disease recurrence or death, Roche said.

This is a landmark approval for people who have always faced a high risk of cancer recurrence after surgery. We are now in a position to bring the transformational benefits of Alecensa to even more people with ALK-positive lung cancer.

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