FDA approves Roche’s Alecensa

The FDA just approved Roche's Alexensa for treatment of newly diagnosed patients with ALK-positive disease. Pfizer's Xalkori was the first drug approved to target tumors that test positive for an ALK gene abnormality and is the current market leader.

In the phase 3 trial that supported Alecensa's new approval, the drug topped Xalkori at holding off cancer growth by a wide margin. Median progression-free survival was 25.7 months for Alecensa patients, compared with 10.4 months for those taking Xalkori.

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