Agios’ Tibsovo (ivosidenib) Receives the US FDA’s Breakthrough Therapy Designation for Patients with Relapsed or Refractory Myelodysplastic Syndrome with an IDH1 Mutation

 Agios’ Tibsovo (ivosidenib) Receives the US FDA’s Breakthrough Therapy Designation for Patients with Relapsed or Refractory Myelodysplastic Syndrome with an IDH1 Mutation

Agios Pharmaceuticals’ Tibsovo (ivosidenib) Receives Approval For R/R Acute Myeloid Leukemia (AML) and IDH1 Mutation

Shots:

  • The FDA’s BT designation is based on MDS arm of P-I dose-escalation and expansion study assessing Tibsovo (500mg) in 12 patients with r/r MDS with a susceptible IDH1 mutation as detected by an FDA-approved test
  • The P-I study results: median treatment duration (11.4mos.); as of Nov 02, 2018, patients showing response (75%); CR (42%); patients who have CR (60% remained relapse-free @12mos.); 75% were transfusion-independent for 56 days or longer
  • Tibsovo is an IDH1 inhibitor, indicated to treat adults with r/r AML with a susceptible IDH1 mutation as detected by an FDA-approved test

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

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

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