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BerGenBio receives Fast Track designation

Richard Godfrey

BerGenBio has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for bemcentinib in combination with an anti-PD-(L)1 agent for the treatment of patients with AXL-positive advanced/metastatic non-small cell lung cancer (NSCLC).

The FDA’s decision represents the first recognition by a regulator of AXL-positive patients as a molecular targetable patient population, states the company in a press release. This 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.

“Building on our encouraging clinical and translational data, we are excited to receive Fast Track designation from the FDA for the promising combination of bemcentinib in combination with a checkpoint inhibitor. This regulatory milestone is particularly meaningful for BerGenBio, as it represents the first formal recognition by a regulator of AXL-positive patients as a discernible patient population and serves as further validation of our belief that AXL inhibition has high potential as a cornerstone of cancer combination therapy,” says Richard Godfrey, Chief Executive Officer of BerGenBio.

Read more: Q&A: Richard Godfrey, CEO of BerGenBio

The Fast Track Designation

The Fast Track Designation will enable BerGenBio to have more frequent interactions with the FDA throughout the drug development process, so that an approved product can reach the market faster.

The designation also provides Eligibility for Accelerated Approval, enabling approval based on a surrogate clinical endpoint; Priority Review, which allows New Drug Application (NDA) review in six months instead of 10, if relevant criteria are met; and eligibility for Rolling Review, whereby the company will be able to submit completed sections of its NDA for review by the FDA before complete application is submitted.

Read more: New trial data about BerGenBio’s bemcentinib in COVID-19 patients

Photo of Richard Godfrey: Nils Olav Mevatne