FDA grants fast track designation to bemcentinib combination for advanced NSCLC
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The FDA granted fast track designation to bemcentinib in combination with an anti-PD-L1 agent for treatment of patients with AXL-positive advanced or metastatic non-small cell lung cancer.
The designation applies to patients who do not have actionable mutations and whose disease progressed during or after first-line treatment with an anti-PD-L1 agent, with or without chemotherapy.
Bemcentinib (BerGenBio) is a highly selective AXL inhibitor in phase 2 development.
AXL expression has been linked to key mechanisms of drug resistance and immune escape by tumor cells, according to a BerGenBio-issued press release. High AXL expression is associated with poor prognosis for most cancers.
Ongoing trials are evaluating the agent in combination with other approaches — such as chemotherapy, immunotherapy or targeted therapy — as treatment for multiple solid tumors and hematologic malignancies.
The agent also is being evaluated for patients with COVID-19.
“We are excited to receive fast track designation from the FDA for the promising combination of bemcentinib in combination with a checkpoint inhibitor,” Richard Godfrey, CEO of BerGenBio, said in the release. “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.”
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