Zymeworks’ Zanidatamab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Biliary Tract Cancer

 Zymeworks’ Zanidatamab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Biliary Tract Cancer

Zymeworks’ Zanidatamab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Biliary Tract Cancer

Shots:

  • The US FDA has granted the BTD for zanidatamab in patients with previously-treated HER2 gene-amplified BTC
  • The designation was based on a P-I trial assessing zanidatamab in patients with BTC. The company has initiated a P-II study, which is designed to support accelerated approval based on 1EPs of ORR, and 2EPs of DoR and safety
  • Zanidatamab will now be eligible for accelerated approval, PR and rolling review as well as intensive FDA guidance on an efficient drug development program. The company plans to submit BLA as early as 2022

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Wikipedia

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post