Daiichi Sankyo scores landmark FDA OK for rare tumor drug — albeit with restrictions

Daiichi Sankyo finally has a regulatory win to celebrate as the FDA sanctions a careful, restricted rollout of pexidartinib, to be marketed as Turalio.

Throughout internal reviews and the advisory committee panel, where it has appeared side by side quizartinib — the acute myeloid leukemia drug slapped down by regulators in June — pexidartinib has emerged as the drug candidate with better chances for approval as it represents a landmark treatment option for a rare tumor. Tenosynovial giant cell tumors are typically benign but can be debilitating as they affect small and large joints.