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Alecensa FDA Approval History

Last updated by Judith Stewart, BPharm on April 21, 2024.

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 anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive non-small cell lung cancer.

Development timeline for Alecensa

DateArticle
Apr 18, 2024Approval FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer
Jun 12, 2023Food-Drug Interactions Could be Impactful for Some Lung Cancer Patients
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

See also

Alecensa (alectinib) Consumer information

Further information

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