FDA Approves Keytruda in Combination with Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer

Nov 02, 2023 07:40 CST Updated 07:40

MSD

Pharmaceutical R&D and Manufacturer

On November 1, MSD announced that the FDA approved Keytruda (pembrolizumab) for a new indication, in combination with chemotherapy (gemcitabine and cisplatin), as a first-line treatment for locally advanced unresectable or metastatic biliary tract cancer (BTC). This is the sixth gastrointestinal cancer indication that Keytruda has received in the United States.

This approval is mainly based on Phase IIIRandomized, Double-blind, Placebo-controlledKEYNOTE-966 Study. The results showed that, compared with chemotherapy alone,KeytrudaCombination therapy significantly improved overall survival in patients (12.7 vs. 10.9 months; P=0.0034), and the study met its primary endpoint.

Source: Lancet

BTC (Including Cholangiocarcinoma and Gallbladder Cancer)Is a group of rare and aggressive gastrointestinal cancers, alsoIt is the second most common (the most common being hepatocellular carcinoma) primary liver cancer, accounting for 15% of all liver cancers.In the United States, every yearApproximately 20,000 patients have been diagnosed with BTC.。Since this disease usually has no obvious symptoms in the early stage,At the time of diagnosis, the majority (70%) of patients are already in the advanced stage, with limited treatment options and poor prognosis. The 5-year relative survival rate for advanced-stage patients is 2%-3%, and the 5-year relative survival rate for all stages is 9%-11%.

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