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| Land | Norge |
|---|---|
| Lista | OB Match |
| Sektor | Hälsovård |
| Industri | Bioteknik |
2021-06-08 07:00:04
First recognition by a regulator of AXL-positive patients as a target population
Bergen, Norway, 08 June 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, today announces 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. 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.
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. It
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