FDA Grants Genentech’s Alecensa Priority Review for Initial Treatment of People with ALK-Positive Lung Cancer

Excerpt:

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Alecensa® (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The FDA will make a decision on approval by November 30, 2017.

” ‘Phase III results showed Alecensa reduced the risk of disease worsening by more than half compared to the current standard of care and lowered the risk of tumors spreading to or growing in the brain by more than 80 percent,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘We are working closely with the FDA to bring this medicine as an initial treatment for people with ALK-positive NSCLC as soon as possible.’ ”

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