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# Fast Track for BerGenBio Lung Cancer Therapy
- URL: https://www.fdaweb.com/fast-track-for-bergenbio-lung-cancer-therapy/
- Published: 2021-06-08T12:00:00.000Z
- Updated: 2026-09-14T17:02:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149489

FDA has granted BerGenBio ASA a fast track designation for bemcentinib in combination with an anti-PD-(L)1 agent for treating patients with AXL-positive advanced/metastatic non-small cell lung cancer. The designation has been granted for patients without actionable mutations, with disease progression on or after treatment with an anti-PD-(L)-1 agent, with or without chemotherapy as their first line of therapy, the company says.

In cancer, an increase in AXL expression has been linked to drug resistance and immune escape by tumor cells, leading to aggressive metastatic cancers, according to BerGenBio. “High AXL expression defines a very poor prognosis subgroup in most cancers,” it says. “AXL inhibitors, such as bemcentinib, therefore, have potential high value as monotherapy and as the cornerstone of cancer combination therapy.”

Bemcentinib is described as a potent and highly selective AXL inhibitor that works by targeting and binding to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and thus inhibiting its activity.