New Drug Application of FGFR inhibitor futibatinib filed with MHLW (Japan) for biliary tract cancer.- Taiho
Taiho Pharmaceutical Co., Ltd. announced that it has submitted to the Japanese Ministry of Health, Labour and Welfare a new drug application for futibatinib (TAS-120), a FGFR inhibitor as a treatment for previously treated locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions.
The NDA submitted is based on the data from the Phase II FOENIX-CCA2 trial. FOENIX-CCA2 trial was a Phase II trial in 103 patients with locally advanced or metastatic unresectable intrahepatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions. In the trial, patients who had received one or more prior lines of systemic therapy received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. The trial’s primary endpoint was objective response rate (ORR) : Percentage of patients with objective evidence of response to anticancer treatment and other treatments. Furthermore, a companion diagnostic device to detect FGFR2 gene rearrangements including gene fusions is being jointly developed in Japan with Sysmex Corporation.
Related news and insights
The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the Phase IIIb COSMOS clinical trial showing that treatment with Tremfya (guselkumab) provided sustainable improvements in all minimal disease activity (MDA)a domains through week 48 in adults living with active psoriatic arthritis (PsA) who previously had an inadequate response to one to two tumor necrosis factor inhibitors (TNFi-IR)
Pfizer Inc. announced the first detailed results from the Phase II PHAROS study, which is evaluating the efficacy and safety of Braftovi (encorafenib) given in combination with Mektovi(binimetinib) to patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC)
Legend Biotech Corp announced that results from the Phase III CARTITUDE-4 study showed that, at a median follow up of 16 months, cilta-cel (ciltacabtagene autoleucel) reduced the risk of disease progression or death by 74 percent compared to standard of care regimens in adult patients with multiple myeloma who have received one to three prior lines of therapy and are refractory to lenalidomide (Hazard ratio [HR]=0.26 (95% CI, 0.18–0.38); P-value [P] <0.0001)