Gilteritinib

Global FLT3 Inhibitors Market Research Report 2022: Focus on Commercialized Therapy & Potential Pipeline Products - ResearchAndMarkets.com

Retrieved on: 
Friday, September 9, 2022

The "FLT3 Inhibitors Market - A Global and Country Analysis: Focus on Commercialized Therapy, Potential Pipeline Product, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "FLT3 Inhibitors Market - A Global and Country Analysis: Focus on Commercialized Therapy, Potential Pipeline Product, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.
  • The current study aims to assess the global FLT3 inhibitors market by focusing on the marketed and potential pipeline therapies.
  • Increasing investments in the research and development of drug manufacturing are one of the major opportunities in the global FLT3 inhibitors market.
  • The growing interest of the pharmaceutical industry in the therapeutic potential for treating blood cancers with FLT3 positive mutations has been a catalyst for the progress of the global FLT3 inhibitors market.

Acute Myeloid Leukemia (AML): Utilizing Single-Cell Multi-Omics to Uncover its Evolution and Resistance Mechanisms, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, April 21, 2021

b'TORONTO, April 21, 2021 /PRNewswire-PRWeb/ --Acute myeloid leukemia (AML) is a highly heterogeneous hematological malignancy characterized by the overproduction of abnormal myeloblasts.

Key Points: 
  • b'TORONTO, April 21, 2021 /PRNewswire-PRWeb/ --Acute myeloid leukemia (AML) is a highly heterogeneous hematological malignancy characterized by the overproduction of abnormal myeloblasts.
  • For patients with FLT3 mutated AML, the FLT3 inhibitors (FLT3i), gilteritinib and quizartinib, can improve patient outcomes.\nHowever, the development of secondary resistance to these drugs remains a major challenge.
  • The acquisition of new mutations and the emergence of new subclones during the course of therapy can drive relapse.
  • Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.\nSydney Perelmutter, Xtalks, +1 (416) 977-6555 x 352, [email protected]\n'

Astellas to Present New Data on Gilteritinib in FLT3 Mutation-Positive Acute Myeloid Leukemia at the 2020 American Society of Hematology Annual Meeting

Retrieved on: 
Monday, November 16, 2020

TOKYO, Nov. 16, 2020 /PRNewswire/ --Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the presentation of new data in acute myeloid leukemia (AML) at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 5-8, 2020.

Key Points: 
  • TOKYO, Nov. 16, 2020 /PRNewswire/ --Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the presentation of new data in acute myeloid leukemia (AML) at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 5-8, 2020.
  • "Several presentations will describe the effects of gilteritinib in a wide range of AML patients with a positive FLT3 mutation.
  • Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib.
  • Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.

Aptose Announces FDA Allowance of IND for Phase 1a/b Study of CG-806 in Acute Myeloid Leukemia

Retrieved on: 
Monday, June 29, 2020

CG-806 is currently in a Phase 1 dose escalation study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkins lymphomas (NHL), who have failed or are intolerant to current therapies.

Key Points: 
  • CG-806 is currently in a Phase 1 dose escalation study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkins lymphomas (NHL), who have failed or are intolerant to current therapies.
  • We are pleased that the FDA has allowed us to initiate a clinical trial in these patients at a starting dose of 450mg BID.
  • Aptose intends to initiate the Phase 1 a/b study in the second half of 2020 in AML patients who have relapsed, are resistant or refractory to current treatment.
  • CG-806 is an oral, first-in-class FLT3/BTK cluster selective kinase inhibitor and is in Phase 1 clinical studies for the treatment of hematologic malignancies.

Diaceutics Collaborates With Industry Advisor Network to Publish Multiple Cancer Insights

Retrieved on: 
Thursday, May 28, 2020

Diaceutics today reveals new data insights into key areas of cancer testing.

Key Points: 
  • Diaceutics today reveals new data insights into key areas of cancer testing.
  • FLT3 2: Diaceutics examined the economic cost of not testing for FLT3 to treat acute myeloid leukemia (AML), a cancer with poor five-year survival rates and high treatment costs.
  • Diaceutics will launch DXRX, the worlds first diagnostic network in precision medicine, in Q4 2020 to help solve these issues through global stakeholder collaboration.
  • Through DXRX, Diaceutics will make these alliances and its real-world data repository available to its network of pharmaceutical, laboratory and diagnostic partners.

Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

Retrieved on: 
Tuesday, May 19, 2020

SAN DIEGO, May 19, 2020 /PRNewswire/ --Invivoscribe to offer the LeukoStrat CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.

Key Points: 
  • SAN DIEGO, May 19, 2020 /PRNewswire/ --Invivoscribe to offer the LeukoStrat CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.
  • In 2017, Invivoscribe's LeukoStrat CDx FLT3 Mutation Assay became the first FDA approved FLT3 test and launched as a testing service at LabPMM, Invivoscribe's clinical laboratory in San Diego.
  • This PMA supplement approval by the FDA provides customers a choice to purchase the IVD-labeled LeukoStrat CDx FLT3 Mutation Assay kits for in-house testing.
  • The LeukoStrat CDx FLT3 Mutation Assay may be used as an aid in assessment of AML patients for treatment with approved FLT3 targeted therapies.

Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

Retrieved on: 
Tuesday, May 19, 2020

SAN DIEGO, May 19, 2020 /PRNewswire/ --Invivoscribe to offer the LeukoStrat CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.

Key Points: 
  • SAN DIEGO, May 19, 2020 /PRNewswire/ --Invivoscribe to offer the LeukoStrat CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.
  • In 2017, Invivoscribe's LeukoStrat CDx FLT3 Mutation Assay became the first FDA approved FLT3 test and launched as a testing service at LabPMM, Invivoscribe's clinical laboratory in San Diego.
  • This PMA supplement approval by the FDA provides customers a choice to purchase the IVD-labeled LeukoStrat CDx FLT3 Mutation Assay kits for in-house testing.
  • The LeukoStrat CDx FLT3 Mutation Assay may be used as an aid in assessment of AML patients for treatment with approved FLT3 targeted therapies.

25th EHA Congress: Menarini Ricerche Discloses First Results From the Clinical Study on SEL24/MEN1703

Retrieved on: 
Thursday, May 14, 2020

The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).

Key Points: 
  • The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).
  • Cohort Expansion study in relapsed/refractory AML patients will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
  • Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,000 employees.
  • The Menarini Group's commitment to precision oncology is also supported by Menarini Silicon Biosystems' technologies and products to study rare cells with single-cell precision.

25th EHA Congress: Menarini Ricerche Discloses First Results From the Clinical Study on SEL24/MEN1703

Retrieved on: 
Thursday, May 14, 2020

The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).

Key Points: 
  • The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).
  • Cohort Expansion study in relapsed/refractory AML patients will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
  • Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,000 employees.
  • The Menarini Group's commitment to precision oncology is also supported by Menarini Silicon Biosystems' technologies and products to study rare cells with single-cell precision.

Invivoscribe Submits LeukoStrat® CDx FLT3 Mutation Assay to NMPA in China and Expands Company, Adding Laboratory in Shanghai to Provide Comprehensive Support for Partners

Retrieved on: 
Tuesday, May 12, 2020

Invivoscribe also announced expansion of its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., adding laboratory testing services to support clinical trials and pharmaceutical partners.

Key Points: 
  • Invivoscribe also announced expansion of its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co. Ltd., adding laboratory testing services to support clinical trials and pharmaceutical partners.
  • Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership with Astellas as the companion diagnostic supporting use of gilteritinib to treat adult patients with relapsed/ refractory FLT3-mutated AML.
  • "This is an announcement of two significant milestones: Submission of our LeukoStrat CDx Assay to the NMPA, and the expansion of our laboratory network into China.
  • The LeukoStrat CDx FLT3 Mutation Assay is the onlyinternationally standardized signal ratio assay that identifies both ITD and TKD mutations of the FLT3 biomarker.