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Lumakras FDA Approval Status

FDA Approved: No
Brand name: Lumakras
Generic name: sotorasib
Company: Amgen Inc.
Treatment for: Non-Small Cell Lung Cancer

Sotorasib is a KRASG12C inhibitor in development for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non- small cell lung cancer (NSCLC), following at least one prior systemic therapy.

Development Timeline for Lumakras

DateArticle
Apr 28, 2021Amgen Provides Updated Information on Lumakras (sotorasib) Dose Comparison Study
Feb 16, 2021FDA Grants Sotorasib Priority Review Designation For The Treatment Of Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Jan 28, 2021Amgen's Investigational KRAS G12C Inhibitor Sotorasib Demonstrated Rapid, Deep And Durable Responses In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Dec  8, 2020Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation
Oct  5, 2020Amgen Announces Positive Topline Phase 2 Results For Investigational KRAS G12C Inhibitor Sotorasib In Advanced Non-Small Cell Lung Cancer
Sep 21, 2020Clinical Data From Full Phase 1 Cohort Of Investigational Sotorasib Published In New England Journal Of Medicine

Further information

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