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# Amgen Wins Approval for Lung Cancer Therapy
- URL: https://www.fdaweb.com/amgen-wins-approval-for-lung-cancer-therapy/
- Published: 2021-05-28T12:00:00.000Z
- Updated: 2026-09-14T17:01:00.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5149431

FDA has approved Amgen’s Lumakras (sotorasib) for treating adult patients with non-small cell lung cancer whose tumors have the KRAS G12C genetic mutation and who have received at least one prior systemic therapy. “This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25% of mutations in non-small cell lung cancers.” an FDA[ release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug?ref=fdaweb.com) says.  

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer," said FDA Oncology Center of Excellence director **Richard Pazdur**. “Today's approval represents a significant step towards a future where more patients will have a personalized treatment approach.”  

Approval was based on data from a study of 124 patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with disease progression after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy. “The objective response rate was 36% and 58% of those patients had a duration of response of six months or longer,” the agency says.  

Additionally, FDA approved Qiagen’s therascreen KRAS RGQ PCR kit and Guardant Health’s Guardant360 CDx as companion diagnostics for determining treatment adequacy.