Incyte biliary tract cancer treatment approved in Japan

pharmafile | March 23, 2021 | News story | Manufacturing and Production EMA, Japan, oncology 

The Japanese Ministry of Health, Labour, and Welfare (MHLW) have approved Incyte’s Pemazyre (pemigatinib) for the treatment of patients with unresectable biliary tract cancer (BTC).

Pemazyre is a selective fibroblast growth factor receptor (FGFR) inhibitor, and is used to treat patients with BTC with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

Lothar Finke, General Manager of Incyte Asia, said: “The MHLW approval of Pemazyre is an important milestone for the BTC community, and underscores our commitment to finding and delivering solutions for patients with significant unmet medical needs.

“BTC is a rare and serious condition, and we are proud that with the support of the MHLW we will be able to bring a new targeted treatment to more patients around the world.”

Previously, the MHLW granted Orphan Drug Designation for Pemazyre, which is a designation granted to investigational compounds intended to treat rare diseases that affect fewer than 50,000 people in Japan, and for which there is deemed a high medical need.

At the end of January, the EMA’s Committee for Medicinal Products for Human Use (CHMP) also issued a recommendation for the Conditional Marketing Authorisation of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement. Cholangiocarcinoma is a subtype of BTC, and occurs on the bile duct inside the liver and also on the liver’s external bile duct.

This is the second approval for Pemazyre, following an FDA approval last year, wherein Pemazyre became the first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma.

Kat Jenkins


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