The U.S. FDA has approved Taiho Oncology Inc.’s Lytgobi (futibatinib) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR-2) gene fusions or other rearrangements. The approval arrived on its Sept. 30 PDUFA date.

The U.S. FDA has approved Taiho Oncology Inc.’s Lytgobi (futibatinib) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR-2) gene fusions or other rearrangements. The approval arrived on its Sept. 30 PDUFA date.

Japan’s Ministry of Health, Labour and Welfare has given Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. the green light for its oral heat shock protein 90 (HSP90) inhibitor Jeselhy (pimitespib) to treat gastrointestinal stromal tumors (GIST) that have progressed after chemotherapy. The company will soon commercialize the drug in Japan.

Cullinan Oncology Inc.’s lead program deal with Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. brings $275 million up front and the potential for as much as $130 million in regulatory milestone payments.

The FDA’s Oncologic Drugs Advisory Committee voted 6-2 April 29 to recommend withdrawing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a third-line treatment for a subgroup of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer. The vote was based on FDA assurances that, if it withdrew the approval, it would work with Merck to delay the withdrawal or set up an access program to ensure the estimated 1,000 patients who are beyond first-line treatment could still get Keytruda.

HONG KONG – Taiho Pharmaceutical Co. Ltd. has signed an exclusive license agreement with Lung Therapeutics Inc., picking up the Japanese rights to Lung Tx’s LTI-01.