Recently, cancer biopharmaceutical company Agios Pharmaceuticals announced that its anticancer drug TIBSOVO (ivosidenib) has been approved by the US FDA for the confirmation of the presence of susceptible isocitrate dehydrogenase by a test method (Abbott RealTime IDH1 Companion Diagnostic Kit) -1 (IDH1) mutation in relapsed or refractory acute myeloid leukemia (R/R AML) adult patients, Tibsovo is an oral targeting inhibitor against IDH1 enzyme, this approval makes Tibsovo the first and The only drug approved by the FDA to treat the IDH1 mutation R/R AML.

AML is characterized by rapid disease progression and is the most common acute leukemia in adults. There are an estimated 20,000 new cases in the United States each year, and most AML patients eventually relapse. The prognosis of R/R AML is poor, with a five-year survival rate of approximately 27%. For 6-10% of AML patients, IDH1 enzyme mutations block normal blood stem cell differentiation, leading to the development of acute leukemia.

The FDA approved TIBSOVO? R/R AML patients with IDH1 mutations are based on clinical data for an open-label, one-arm, multi-center, dose escalation and amplification trial AG120-C-001. The study included 174 patients who received 500 mg of TIBSOVO per day. The initial dose is administered orally until disease progression, unacceptable toxicity, or the need for hematopoietic stem cell transplantation. The primary endpoint of the study was combined complete remission (CR) and complete remission (CRh) with partial hematologic improvement. CRh is defined as <5% of blast cells in the bone marrow without signs of disease and partial recovery of peripheral blood counts (platelets > 50,000 / microliter and ANC > 500 / microliter).

The final clinical results showed that the CR+CRh rate of Tibsovo was 32.8% (n=57/174, 95% CI: 25.8-40.3), and the CR rate was 24.7% (n=43/174, 95% CI: 18.5-31.8), CRh rate was 8% (n=14/174, 95% CI: 4.5-13.1); CR+CRh median duration was 8.2 months (95 %CI: range 5.6-12 months), in patients with CR or CRh, the median time from treatment to CR or CRh was 2.0 months (range: 0.9-5.6) Of the 110 patients who were dependent on red blood cell (RBC) and/or platelet transfusion at baseline, 41 (37.3%) did not rely on RBC and platelet transfusion 56 days after baseline; baseline did not rely on RBC Of the 64 patients who received platelet transfusion, 38 (59.4%) remained independent of infusion at 56 days after baseline; 21 of 174 patients (12%) received stem cells after receiving Tibsovo therapy. transplant.

Hagop M., Chairman, Leukemia Department, MD Anderson Cancer Center, University of Texas, USA Professor Kantarjian said that there are few treatment options for patients with R/R AML. Clinical studies have shown that Tibsovo can provide powerful long-lasting relief and can help patients achieve and maintain independent infusion. For AML patients carrying IDH mutations, IDH inhibitors represent a new class of non-cytotoxic targeted therapies.

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