FDA accepts supplemental new drug application for crizotinib for treatment of paediatric ALK-positive anaplastic large cell lymphoma

The FDA submission is supported by results from Study ADVL0912 and A8081013 and is in addition to the European Medicines Agency’s agreement on a Pediatric Investigational Plan for crizotinib and represents a step forward for a potential regulatory submission in the EU.

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Biospace Inc.