FDA has granted IDH1 inhibitor Tibsovo (ivosidenib) breakthrough therapy designation
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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today, drug company Agios Pharmaceuticals(http:// announcedthat the U.SFDA(http://has awarded the IDH1 inhibitor Tibsovo (ivosidenib) breakthrough therapy to treat recurrent/incurable bone marrow hyperplasia syndrome that carries the allergenic IDH1 gene mutationAbout Tibsovo
Tibsovo is an IDH1 inhibitor that has been approved by the FDA to treat patients with recurrent/refractory AML who carry a allergenic IDH1 gene mutationAgios published the results of Tibsovo as a single-drug therapy, a Phase 1 clinicaltrial(http://) for MDSThe results showed that Tibsovo had good tolerance and was associated with persistent remission and realization and maintenance of blood transfusion independence in patients with recurrent/refractory MDS with the IDH1 gene mutationstudiesof 12 patients treated with Tibsovo, 75% (9/12) responded and 42% (5/12) received complete remission (CR) as of 2 November 2018In 60% of patients who received CR, they did not relapse at 12 months, and the median CR duration has not yet been reached in addition, nine (75%) patients were not dependent on blood transfusions for 56 days or more during the study
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