AML remission period first-line maintenance treatment of new drugs! TimeYUYCC-486 gets FDA priority review

This NDA is based on the efficacy and safety results of the key Phase III QUAZAR AML-001 studyThe study was conducted in a newly diagnosed AML patient who received remission after intensive induction chemotherapy and evaluated the efficacy and safety of CC-486 (oral azastine) as a first-line maintenance therapyThe results showed that the total survival (median OS: 24.7 months vs14.8 months, p.0009) and non-recurrent recurrent (median PFS: 10.2 months vs 4.8 months, p-0.0001) improved statistically and clinically significant in the first-line maintenance therapy group compared to the placebo groupacute myeloid leukemia (AML) is the most common type of acute leukemiaAML starts in the bone marrow, but quickly enters the bloodstreamUnlike normal blood cell development, in AML, the rapid build-up of abnormal white blood cells in the bone marrow may interfere with the production of normal blood cells, leading to a reduction in healthy white blood cells, red blood cells, and plateletsAML is a complex and diverse disease associated with multiple genetic mutations that, if left untreated, usually worsen rapidlyCC-486 (oral azastine) is an oral low methylator that binds to DNA and RNA, allowing for continuous epigenetic regulation due to prolonged exposureAt present, CC-486 is being developed as an epigenetic modifier for the treatment of a variety of blood tumorsThe main mechanism of the drug's action is thought to be low methylation of DNA and direct cytotoxicity to abnormal hematopoietic cells in bone marrowLow methylation may restore normal function of genes that are essential for differentiation and proliferation"Usually, newly diagnosed adult patients with acute myeloid leukemia can be fully alleviated through induction therapy, but many patients relapse and experience poor results," said DrNoah Berkowitz, Senior Vice President of Global Clinical Development, Global Clinical Development at.SBaishi MeishipoPatients with remission are looking for treatment seeking treatment that reduces the likelihood of recurrence and prolongs overall survival Today's FDA acceptance of our CC-486 NDA is an important step toward addressing the urgent medical needs of AML patients for potential new maintenance treatments, and we look forward to working closely with the FDA during the review of CC-486 QUAZAR AML-001 is an international, randomized, double-blind, placebo-controlled Phase III study in which patients were aged 55, initially (denovo) or secondary acute myeloid leukemia, with moderate or high risk cytogenetics, first complete remission (CR) after intensive induction chemotherapy (CR) or complete remission with incomplete blood image recovery (CRi) According to the researchers' choice, patients received intensive induction chemotherapy, had or did not have solid chemotherapy, and were not considered candidates for hematopoietic stem cell transplantation (HSCT) prior to the start of the study   After intensive induction chemotherapy, 81% of patients reached CR and 19% reached CRi Eighty percent of patients received consolidation therapy for at least one cycle before participating in the study The 472 patients were then randomly divided into two groups with a ratio of 1:1, followed by CC-486 300 mg treatment (n-238), placebo treatment (n-234), once a day, 14 days per cycle, one cycle every 28 days In the study, the patient continued to receive treatment until unacceptable toxicity or disease progression   The median follow-up group showed significant improvement in the main os endpoint compared to the placebo group at 41.2 months The cc-486 treatment group had a median OS of 24.7 months from randomization time, compared with 14.8 months in the placebo group (p-0.0009; HR-0.69.95% CI: 0.55, 0.86) For the critical secondary endpoint RFS, the cc-486 treatment group had 10.2 months of median RFS and the placebo group 4.8 months (p-0.0001; HR-0.65.95.5%CI:0.52, 0.81) The CC-486 treatment group HAD an improvement in OS and RFS compared to the placebo group, regardless of cytogenetic risk category, past consolidation, or CR/CRi status at the time of group entry Compared to the placebo group, the health-related quality of life (HRQoL) in the CC-486 treatment group remained unchanged from the baseline level   The median course of treatment for CC-486 was 12 cycles (1-80) and placebo was 6 cycles (1-73) The most common adverse events (AE) of all levels of CC-486 and placebo were nausea (65 percent vs 24 percent), vomiting (60 percent vs 10 percent) and diarrhea (50 percent vs 22 percent) The most common level 3-4 adverse events in CC-486 and placebo were neutropenocytic cell reduction (41% vs 24%), platelet reduction (23% vs 22%), and anemia (14% vs 13%) In the CC-486 treatment group and 25% of patients in the placebo group, 34% and 25% of patients had severe adverse events, mainly infections, occurring in 17% and 8% of patients in two groups, respectively In the CC-486 treatment group and placebo group, 13% and 4% of patients stopped treatment because of AE, respectively original origin: U.S Food and Drug Administration (FDA) For The Fda, The Essentials for Review Bristol Myers Squibb's sapplication for CC-486 for Maintenance Treatment of Adult Patients in Re Re Myeloid Leukemia original title: Acute Myelo Leukemia (AML) Remission Phase 1St Maintenance New Drug! Boxei CC-486 (oral azastine) by the U.S FDA priority review!