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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: sotorasib
Trade Name: Lumakras
Date Designated: 05/01/2019
Orphan Designation: Treatment of KRAS p.G12C-positive non-small cell lung cancer
Orphan Designation Status: Designated/Approved
Amgen Inc.
1 Amgen Center Drive
Mail Stop 27-3-A
Thousand Oaks, California 91320
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: sotorasib
Trade Name: Lumakras
Marketing Approval Date: 05/28/2021
Approved Labeled Indication: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Exclusivity End Date: 05/28/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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