Brief: Bergenbio Receives FDA Fast Track Designation For Bemcentinib / Anti-PD-(L)1 Combination In NSCLC

Oncoinvent ASA

08/06/2021 06:07

June 8 (Reuters) - Bergenbio ASA  BGBIO.OL :
    * BERGENBIO RECEIVES FDA FAST TRACK DESIGNATION FOR
BEMCENTINIB /
ANTI-PD-(L)1 COMBINATION IN NSCLC
    * FDA HAS GRANTED FAST TRACK DESIGNATION FOR BEMCENTINIB IN
COMBINATION WITH AN ANTI-PD-(L)1 AGENT FOR TREATMENT OF PATIENTS
WITH AXL-POSITIVE ADVANCED/METASTATIC NON-SMALL CELL LUNG CANCER
(NSCLC)
    * DESIGNATION ALSO PROVIDES ELIGIBILITY FOR ACCELERATED
APPROVAL,
ENABLING APPROVAL BASED ON A SURROGATE CLINICAL ENDPOINT
    * IT PROVIDES PRIORITY REVIEW, WHICH ALLOWS NEW DRUG
APPLICATION
(NDA) REVIEW IN SIX MONTHS INSTEAD OF 10, IF RELEVANT CRITERIA
ARE MET
    * ELIGIBILITY FOR ROLLING REVIEW, WHEREBY COMPANY WILL BE
ABLE TO
SUBMIT COMPLETED SECTIONS OF ITS NDA FOR REVIEW BY FDA BEFORE
COMPLETE APPLICATION IS SUBMITTED

Source text for Eikon:  ID:nWkr5yND2j 
Further company coverage:  BGBIO.OL 

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