- In November 2023, Merck & Co., Inc. received the U.S. FDA approval for KEYTRUDA, anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). This approval marked the sixth indication for KEYTRUDA in gastrointestinal cancer, and helped the company expand its sales
- In February 2023, AstraZeneca, a global biopharmaceutical company, had received approval from the Central Drugs Standard Control Organisation (CDSCO) to introduce Durvalumab for treating biliary tract cancer (BTC) in India. BTC encompasses a set of uncommon and aggressive gastrointestinal (GI) cancers originating from the cells of the bile ducts (cholangiocarcinoma), gallbladder, or ampulla of Vater (junction of the bile and pancreatic ducts with the small intestine)
- In July 2021, Pemigatinib (Pemazyre) was approved by the National Institute of Health and Care Excellence (NICE) for patients with a rare form of bile duct cancer known as FGFR2-positive cholangiocarcinoma, which has advanced or spread following initial chemotherapy. Kruti Shrotri of Cancer Research U.K. praises the decision, emphasizing its significance in broadening treatment possibilities for patients grappling with the rarity and treatment resistance of their cancer
- In April 2020, the U.S. Food and Drug Administration had approved the first targeted treatment for patients with cholangiocarcinoma called Pemazyre (pemigatinib). Pemazyre's approval was based on the findings of a clinical trial in which 107 patients with locally advanced or metastatic cholangiocarcinoma who had previously received therapy and had a FGFR2 fusion or rearrangement were enrolled
- In April 2020, Incyte received the U.S. FDA approval for Pemazyre (pemigatinib), a kinase inhibitor, as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma. Pemazyre was the first targeted treatment approved for this specific patient population, giving the company a competitive edge in the market
