Lumakras FDA Approval History

Last updated by Judith Stewart, BPharm on June 2, 2021.

FDA Approved: Yes (First approved May 28, 2021)
Brand name: Lumakras
Generic name: sotorasib
Dosage form: Tablets
Company: Amgen Inc.
Treatment for: Non-Small Cell Lung Cancer

Lumakras (sotorasib) is a KRAS^G12C inhibitor 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.

• This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

  Development timeline for Lumakras

  Date	Article
  Dec 26, 2023	Amgen Provides Regulatory Update on Status of Lumakras (sotorasib)
  May 28, 2021	Approval FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
  Apr 28, 2021	Amgen Provides Updated Information on Lumakras (sotorasib) Dose Comparison Study
  Feb 16, 2021	FDA 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, 2021	Amgen'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, 2020	Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation
  Oct  5, 2020	Amgen Announces Positive Topline Phase 2 Results For Investigational KRAS G12C Inhibitor Sotorasib In Advanced Non-Small Cell Lung Cancer
  Sep 21, 2020	Clinical Data From Full Phase 1 Cohort Of Investigational Sotorasib Published In New England Journal Of Medicine

  See also

  Lumakras (sotorasib) Consumer information

  Further information

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