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Alecensa Approval History

FDA Approved: Yes (First approved December 11, 2015)
Brand name: Alecensa
Generic name: alectinib
Dosage form: Capsules
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer

Alecensa (alectinib) is an oral, anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive non-small cell lung cancer (NSCLC).

Development History and FDA Approval Process for Alecensa

DateArticle
Nov  6, 2017Approval FDA Approves Alecensa (alectinib) as First-Line Treatment for ALK-Positive Metastatic Non-Small Cell Lung Cancer
Jun  5, 2017Phase III Study Showed Genentech’s Alecensa (Alectinib) Reduced the Risk of Disease Progression or Death by More Than Half Versus Crizotinib as First-Line Treatment in a Specific Type of Lung Cancer
Dec 11, 2015Approval FDA Approves Alecensa (alectinib) for ALK-Positive Non-Small Cell Lung Cancer
Sep  8, 2015FDA Grants Genentech's Alectinib Priority Review for Specific Type of ALK-Positive Lung Cancer
May 13, 2015Genentech’s Investigational Medicine Alectinib Shrank Tumors in Nearly Half of People with Specific Type of Lung Cancer

Further information

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