Found 18 articles
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced several initiatives to enhance corporate governance and long-term shareholder value creation.
Daiichi Sankyo Demonstrates Breadth and Depth of Oncology Portfolio Across Multiple Cancers with New Data at ESMO Asia, SABCS and ASH
Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio in multiple types of solid and blood cancers at the 2023 ESMO Asia Congress (#ESMOAsia23), San Antonio Breast Cancer Symposium (#SABCS23) and American Society of Hematology (#ASH23) Annual Meeting prior to its annual R&D Day.
Daiichi Sankyo (TSE: 4568) today announced that VANFLYTA® (quizartinib) is now available by prescription in the U.S. VANFLYTA is the first and only FLT3 inhibitor to be approved by the U.S. Food and Drug Administration (FDA) specifically for FLT3-ITD positive acute myeloid leukemia (AML) and across the three phases of treatment – induction, consolidation and maintenance in patients without transplant – for newly diagnosed AML.
Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected by Daiichi Sankyo to be a specialty pharmacy partner for VANFLYTA® (quizartinib).
After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML for Treatment with VANFLYTA
Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA®.
VANFLYTA® First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML
Daiichi Sankyo (TSE: 4568) today announced that VANFLYTA® (quizartinib) has been approved by the U.S. Food and Drug Administration (FDA) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test.
Invivoscribe Announces Updated Reimbursement for the LeukoStrat CDx FLT3 Mutation Assay to Select Newly Diagnosed FLT3-ITD Positive AML Patients Eligible for VANFLYTA in Japan
Invivoscribe is pleased to announce that their LeukoStrat CDx FLT3 Mutation Assay® has received updated reimbursement by Japan's Ministry of Health, Labor and Welfare to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA®.
Quizartinib Plus Chemotherapy Significantly Improved Overall Survival Compared to Chemotherapy in Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia
Positive results from the global pivotal QuANTUM-First phase 3 trial of Daiichi Sankyo’s quizartinib combined with standard induction and consolidation chemotherapy and then continued as a single agent demonstrated a statistically significant and clinically meaningful improvement in overall survival in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive acute myeloid leukemia compared to standard chemotherapy alone.
Daiichi Sankyo Showcases Bold Leadership in Oncology with Survival Improvements for Certain Patients with Cancer at ASCO and EHA
Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio at the 2022 American Society of Clinical Oncology Scientific Program (#ASCO22) and the European Hematology Association Congress (#EHA22).
Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed FLT3-ITD Positive AML
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced positive topline results from the global pivotal QuANTUM-First phase 3 trial evaluating quizartinib, a highly potent and selective FLT3 inhibitor, in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML).
Daiichi Sankyo to Present New Preclinical and Translational Research from DXd ADC Portfolio at AACR Virtual Annual Meeting II
Preclinical and biomarker research data will be reported for U3-1402 (HER3 DXd ADC) in HER3 expressing cancers including combination with osimertinib in EGFR mutated NSCLC Presentations for several of Daiichi Sankyo’s DXd ADCs highlight potential for further expansion of clinical development program to new targets and tumor types BASKING RIDGE, N.J. & MUNICH--( BUSINESS WIRE )-- Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo
Invivoscribe Submits LeukoStrat® CDx FLT3 Mutation Assay to NMPA in China and Expands Company, Adding Laboratory in Shanghai to Provide Comprehensive Support for Partners
Invivoscribe is pleased to announce that their LeukoStrat® CDx FLT3 Mutation Assay was submitted to regulatory authorities in China in April in support of the Astellas New Drug Application submission of XOSPATA® for treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation.
Daiichi Sankyo Data at ASH Showcases Scientific and Clinical Advancements Across AML/Blood Cancer Portfolio
Three oral presentations to feature analyses from global pivotal phase 3 QuANTUM-R study of quizartinib
Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Daiichi Sankyo Company, Limited announced that the company received a Complete Response Letter from the U.S. Food and Drug Administration for the New Drug Application of quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia.
Daiichi Sankyo's VANFLYTA® Receives Approval in Japan for the Treatment of Relapsed/Refractory FLT3-ITD AML
VANFLYTA® (quizartinib) is a FLT3 inhibitor MHLW-approved based on a survival benefit compared to salvage chemotherapy in adult patients with relapsed/refractory FLT3-ITD AML