FDA panel gives a thumbs up and a thumbs down to Daiichi cancer drugs

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has voted in favor of approving one cancer drug from Japanese drugmaker Daiichi Sankyo (TYO: 4568) but voted against another one.

There were 12 votes in favor and three against pexidartinib, and if the agency follows the panel’s recommendation, then it will become the first and only approved therapy for tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations, and not amenable to improvement with surgery.

The votes suggest that the benefit outweighs the risks in the treatment of adult patients with symptomatic TGCT, though the FDA will make its final decision by early August, having granted pexidartinib a priority review voucher.