FDA Grants

FDA Grants BerGenBio Fast-Track Designation for NSCLC Combination

June 10, 2021

The FDA has granted Fast-Track designation to BerGenBio’s Bemcentinib in combination with an anti-PD-(L)1 therapy for patients with AXL-positive advanced or metastatic nonsmall-cell lung cancer (NSCLC).

Bemcentinib is an AXL kinase inhibitor currently being evaluated in several clinical trials for solid and hematological tumors and for COVID-19 as a monotherapy and in combination with a range of other therapies.

The Fast-Track designation is for treatment of NSCLC 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.

AXL inhibition has a “high potential” to become a cornerstone of cancer combination therapy, says BerGenBio CEO Richard Godfrey.

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