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

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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

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

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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