FDA Approves First Therapy for Rare Tumor

August 8, 2019

The FDA on August 2 approved the first treatment for tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

The drug, Turalio (pexidartinib), is manufactured by Daiichi Sankyo.

The FDA granted this application Breakthrough Therapy designation and Priority Review designation. Turalio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Read the full press release.