Norway's BerGenBio Gets FDA Fast Track Designation For Bemcentinib/Anti-PD-(L)1 Combination In NSCLC

BerGenBio ASA, a Norway-based clinical-stage biopharmaceutical company, announced Tuesday that the U.S. Food and Drug Administration or 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 or NSCLC.

The company focused on developing novel, selective AXL kinase inhibitors for severe unmet medical need noted that the FDA's decision represents the first recognition by a regulator of AXL-positive patients as a molecular targetable patient population.

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.

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.

Bemcentinib, formerly known as BGB324, is a potential first-in-class, potent and highly selective AXL inhibitor, currently in a broad phase II clinical development programme. It is administered as an oral capsule and taken once per day.

Ongoing clinical trials are investigating bemcentinib in COVID-19, and multiple solid and haematological tumours, in combination with current and emerging therapies, and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity.

FDA's Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.

With the designation, BerGenBio can now 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; Priority Review; and eligibility for Rolling Review.

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