Roche: FDA grants priority review for Alecensa.
(CercleFinance.com) - Roche announced today that the US 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.
“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.
Roche expects the FDA's decision on approval at the end of November.
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“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.
Roche expects the FDA's decision on approval at the end of November.
Copyright (c) 2017 CercleFinance.com. All rights reserved.