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FDA NewsLung CancerNewsworthy

Alecensa a New First-Line Treatment for Lung Cancer with ALK Mutation

In November 2017, the FDA approved Alecensa for the treatment of all patients with metastatic non–small-cell lung cancer (NSCLC) and ALK mutation.

December 2017 Vol 3 No 6 – December 18, 2017

On November 6, 2017, the FDA approved Alecensa (alectinib; from Genentech) for the treatment of all patients with metastatic non–small-cell lung cancer (NSCLC) and ALK mutation, as detected by a test designed specifically to detect this mutation. Alecensa was previously approved for patients with metastatic NSCLC and ALK mutation whose disease progressed during, or who are intolerant of, Xalkori (crizotinib) therapy.

ALK-positive lung cancer is often found in younger people, who tend to have more advanced disease at the time of diagnosis, and comes with a unique set of challenges,” said Bonnie J. Addario, a lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation.

The FDA approved Alecensa for these 2 uses based on clinical trials showing that Alecensa significantly improved outcomes and reduced the risk of disease progression compared with Xalkori. The most common side effects with Alecensa are fatigue, constipation, edema, myalgia, and anemia.

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Last modified: January 3, 2018

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