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June 1, 2021Truseltiq Approved to Treat Aggressive Bile Duct Cancer
June 1, 2021 – The U.S. FDA has granted accelerated approval to TruseltiqTM (infigratinib), manufactured by BridgeBio and Helsinn Therapeutics, to treat adults who have previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
CCA, or bile duct cancer, forms inside the tubes that carry digestive fluid through the liver. It’s a rare and aggressive cancer with a median five-year survival rate of just 9%. Risk factors for developing CCA include smoking, age, liver fluke infection, congenital bile duct abnormality, chronic liver disease, and primary sclerosing cholangitis (a progressive disease that causes scarring of the bile ducts).
In a clinical trial, Truseltiq had a confirmed objective response rate of 23% and a five-month median duration of response. Recommended dosing is 125mg taken by mouth once daily for 21 days followed by seven days off therapy. This 28-day cycle is repeated until disease progression or unacceptable toxicity occur. Truseltiq should be taken on an empty stomach at least one hour before or two hours after food, at approximately the same time each day. Dosage adjustment may be required based on liver function, adverse reactions, and other medications the patient may be taking.
Truseltiq has launched at a wholesale acquisition cost (WAC) of $21,500 per 28-day cycle.