FDA greenlights Otsuka subsidiary's bile duct cancer drug

03 Oct 2022
endpts.com
Accelerated ApprovalCollaborate
Otsuka subsidiary Taiho Oncology nabbed an accelerated approval on Friday for Lytgobi (futibatinib), its new kinase inhibitor to treat adults with a type of previously treated bile duct cancer, known as metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. The accelerated approval (meaning a confirmatory trial is necessary to show clinical benefit) follows a shortened six-month review, thanks to the FDA’s Real-Time Oncology Review program. Lytgobi’s approval is based on an overall response rate and duration of response from a single-arm trial that enrolled 103 patients. As determined by an independent review committee according to RECIST v1.1., FDA said, ORR was 42% (95% Confidence Interval [CI]: 32, 52); all 43 responders achieved partial responses. The median DoR was 9.7 months (95% CI: 7.6, 17.1). Taiho looks to separate futibatinib, a novel irreversible FGFR 1-4 inhibitor, from the other approved FGFR inhibitors, like Janssen’s Balversa (erdafitinib) and Incyte’s Pemazyre (pemigatinib), which it says are reversible ATP-competitive inhibitors. Cholangiocarcinoma is diagnosed in about 8,000 individuals each year in the US. Taiho did not announce the price of Lytgobi. The most common side effects from taking the pill, seen in 20% or more of patients, were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting. This is the third approval in the US for Taiho, after it won approval in 2015 for Lonsurf (trifluridine and tipiracil) for the treatment of patients with metastatic colorectal cancer, and Inqovi (decitabine and cedazuridine) in 2020 for the treatment of adults with intermediate and high-risk myelodysplastic syndromes, including chronic myelomonocytic leukemia. Building off its KRAS work with Merck and other co-development deals, Taiho recently extended its partnership with Cullinan Oncology for $275 million to co-develop and co-commercialize CullinanCullinan’s lead program, CLN-081/TAS6417, which is an EGFR inhibitorEGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild-type EGFR.
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