New Drugs Approved In August


The FDA approved Turalio (pexidartinib), developed by Daiichi Sankyo Company, Limited (DSNKY) on August 2, 2019, for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) which is not responsive to surgery.

TGCT is a tumour that affects the synovium- a layer of soft tissues that covers the joints, and tendon sheaths- a layer of membrane that covers tendons. Turalio, the first FDA approved drug for this rare joint tumour carries the tags of breakthrough therapy and orphan drug.

Turalio comes with a boxed warning for hepatotoxicity due to the risk of serious and potentially fatal liver injury.

The drug is under regulatory review by the European Medicines Agency (EMA) and has received Orphan Drug designation.