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FDA accepts sBLA for Keytruda as adjuvant therapy for stage IB ( greater than 4 centimeters) following complete surgical resection.

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Published:14th Jun 2022

Merck Inc., announced the FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda for the adjuvant treatment of patients with stage IB ( greater than 4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection.

The sBLA is based on data from the pivotal Phase III KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP).

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 29, 2023, however, further data may be provided during the review process that may delay this date.

Condition: Non Small Cell Lung Cancer
Type: drug

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