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BridgeBio and Helsinn's Truseltiq (infigratinib) Receive the US FDA's Approval for Cholangiocarcinoma

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BridgeBio and Helsinn's Truseltiq (infigratinib) Receive the US FDA's Approval for Cholangiocarcinoma

BridgeBio and Helsinn's Truseltiq (infigratinib) Receive the US FDA's Approval for Cholangiocarcinoma

Shots:

  • The approval is based on a P-II study assessing Truseltiq (125mg- qd- for 21 days of 28-day cycles) in 108 patients who had undergone at least one prior treatment for advanced CCA. Out of 108- 107 had Stage IV CCA
  • Results: ORR (23%); mDOR (5mos.); presented at ASCO 2021. Additional marketing applications for Truseltiq are currently under review in Australia and Canada under Project Orbis
  • Truseltiq is an ATP-competitive- TKI of FGFR. BridgeBio- through its affiliate QED & Helsinn will co-commercialize Truseltiq in the US under its collaboration signed in Mar’2021

  Ref: Bridge Bio | Image: PR Newswire

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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