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