Juniper Biologics license agreement with Helsinn for infigratinib

Singapore-based Juniper Biologics and privately-held Swiss drugmaker Helsinn Group have signed an exclusive license agreement to develop and commercialize infigratinib (INN) in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

In 2021 infigratinib obtained accelerated approval from the US Food and Drug Administration (FDA) under the brand name Truseltiq for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is based on overall response rate and duration of response.

Additionally, infigratinib received conditional approval by Health Canada and provisional approval by the Therapeutics Goods Association in Australia for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement. Continued approval in the USA, Canada and Australia for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).