Agios Pharmaceuticals cancer drug TIBSOVO (ivosidenib) gets FDA approval

recently, cancer bio
Pharmaceutical(
Pharmaceuticals) announced that its anticancerdrug(ivosidenib) was approved by the U.SFDA(for use in an adult with atesting(Abbott RealTimeIDH1 accompanying diagnosticreagent(box) to confirm the presence of recurrent or refractory acute myeloid leukemia (Ri1) mutationsTibsovoTibsovo is an oral target inhibitor for the IDH1 enzyme, which makes Tibsovo the first and only drug to receive FDA approval to treat the IDH1 mutation R/R AMLFDA-approved TIBSOVO for R/R AML patients with IDH1 mutations is based on clinical data on an open label, single arm, multicenter, dose increment, and amplificationtrialThe study included 174 patients who administered orally at a starting dose of 500 mg of TIBSOVO per day until the disease progressed, unacceptable toxicity occurred, or hematopoietic stem cell transplantation was required The main endpoints of studies were combined with complete remission (CR) and partial hematological improvement (CRh) rates CRh is defined as 5% of the embryonic cells in the bone marrow with no signs of disease and partial recovery of peripheral blood counts (platelets 50,000 / microliter and ANC 500 / microliter) the final clinical results showed that Tibsovo's CR-CRh rate was 32.8% (n-57/174,95% CI: 25.8-40.3), of which the CR rate was 24.7% (n-43/174,95 %CI: 18.5-31.8), CRh rate of 8% (n?14/174, 95%CI: 4.5-13.1); CR-CRh median duration 8.2 months (95% CI: range 5.6) -12 months), from treatment to obtaining THE median remission of CR or CRh 2.0 months (range: 0.9-5.6 months); Of the cases, 41 (37.3%) did not rely on RBC and platelet infusion sat for 56 days after the baseline, and 38 (59.4%) of 64 patients who did not rely on RBC and platelet infusion at baseline The infusion was still not dependent for 56 days after the baseline, and 21 (12%) of the 174 patients received stem cell transplants after receiving Tibsovo treatment clinical studies have shown that Tibsovo provides powerful long-lasting remission and can help patients achieve and remain dependent on infusions For AML patients with IDH mutations, IDH inhibitors represent a new class of non-cell toxic target therapies