Laboratoires Servier

New Analyses from Pivotal Phase 3 INDIGO Study Reinforce Vorasidenib's Potential to Change the Treatment Paradigm for IDH-Mutant Diffuse Glioma

Retrieved on: 
Saturday, November 18, 2023

BOSTON, Nov. 18, 2023 /PRNewswire/ -- New data from Servier's clinical development program for vorasidenib in IDH-mutant diffuse glioma, presented at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) in Vancouver, Canada, showed that vorasidenib reduced tumor growth as measured by a blinded independent radiology committee. Additional data from the INDIGO study being presented at SNO include health-related quality of life data, indicating patients receiving vorasidenib experience preservation of quality of life, stable neurocognitive function, and seizure control, as well as translational data demonstrating vorasidenib's efficacy across IDH-mutant diffuse gliomas with various additional mutations.

Key Points: 
  • We are honored and excited at the prospect of ushering in a new era of targeted treatment options for patients living with this devastating disease."
  • The safety lead-in was conducted to determine the recommended combination dose for the recently initiated perioperative phase of the study.
  • In this phase, approximately 60 patients will be randomized to the combination treatment, vorasidenib 40 mg once-daily alone, or no treatment prior to surgery.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Global Acute Myeloid Leukemia (AML) Treatment Market Trends and Forecasts, 2020-2022 & 2023-2028 with Profiles of Major Players - AbbVie, Daiichi Sankyo, GlaxoSmithKline, Pfizer and Servier - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 24, 2023

The "Global Acute Myeloid Leukemia (AML) Treatment Market: Forecast and Trends" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Acute Myeloid Leukemia (AML) Treatment Market: Forecast and Trends" report has been added to ResearchAndMarkets.com's offering.
  • The global AML treatment market was valued at nearly $3.5 billion in 2022.
  • This study's primary objective is to conduct a comprehensive analysis of the AML treatment market, offering insights into its dynamics, prevailing trends, and the overall market landscape.
  • Technological advancements in the field of blood cancer have played a pivotal role in propelling the AML treatment market forward.

Servier Announces FDA Approval of TIBSOVO® (ivosidenib tablets) for the Treatment of IDH1-Mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)

Retrieved on: 
Tuesday, October 24, 2023

BOSTON, Oct. 24, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced the U.S. Food and Drug Administration (FDA) has approved TIBSOVO® (ivosidenib tablets) for the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). This is the fifth indication for TIBSOVO across IDH1-mutated cancers, and the first and only approved targeted therapy for people diagnosed with R/R MDS within this molecularly defined subset.

Key Points: 
  • "Servier is proud to lead the way in mutant IDH inhibition through continued innovations that support patients living with difficult and hard-to-treat cancers," said Arjun Prasad, Head of Commercial, Servier Pharmaceuticals.
  • "As the first and only targeted therapy available for patients with IDH1-mutated relapsed or refractory myelodysplastic syndromes, today's FDA approval for TIBSOVO reinforces our commitment to deliver significant advances in areas of high unmet need and bring the right treatment, to the right patient, at the right time."
  • "This new indication in IDH1-mutated relapsed or refractory myelodysplastic syndromes reinforces the importance of mutational testing to inform treatment decisions and potentially improve patient outcomes."
  • "Before today, there were no approved targeted therapies available to relapsed or refractory MDS patients harboring the IDH1-mutation.

Elsevier Launches New Pharmapendium, Empowering Pharma Companies to Bring Novel Drugs to Market Faster and Increase Success of Regulatory Submissions

Retrieved on: 
Tuesday, October 10, 2023

Comprehensive drug development and approval package data combined with predictive analytics support translational research, reduce animal testing and ensure drug safety

Key Points: 
  • PharmaPendium enables companies to make faster, more informed decisions about what drug candidates to advance.
  • Pharma professionals and researchers can use the tool to benchmark against competitors, prioritize safety and efficacy, and develop effective strategies for regulatory submissions.
  • The depth and reliability of the platform's data means PharmaPendium is already trusted by the FDA, Pharmaceuticals and Medical Devices Agency (PMDA) and the top 20 global pharma companies.
  • "This improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies."

#UseHeart movement rallies for change as heart disease continues to claim most lives

Retrieved on: 
Friday, September 29, 2023

The global #UseHeart movement springs from the annual World Heart Day campaign to drive year-long awareness and action to reverse the debilitating impacts of CVD.

Key Points: 
  • The global #UseHeart movement springs from the annual World Heart Day campaign to drive year-long awareness and action to reverse the debilitating impacts of CVD.
  • Professor Daniel J. Piñeiro, President of WHF said: "The figures are so staggering that in 2013, ischaemic heart disease featured in the Guinness Book of World Records.
  • CVD prevalence can be traced to gaps in care systems, variable access to prevention, diagnosis, and treatment.
  • "Through World Heart Day and the year-long #UseHeart movement, the World Heart Federation reaches more than 2 billion people every year.

#UseHeart movement rallies for change as heart disease continues to claim most lives

Retrieved on: 
Friday, September 29, 2023

The global #UseHeart movement springs from the annual World Heart Day campaign to drive year-long awareness and action to reverse the debilitating impacts of CVD.

Key Points: 
  • The global #UseHeart movement springs from the annual World Heart Day campaign to drive year-long awareness and action to reverse the debilitating impacts of CVD.
  • Professor Daniel J. Piñeiro, President of WHF said: "The figures are so staggering that in 2013, ischaemic heart disease featured in the Guinness Book of World Records.
  • CVD prevalence can be traced to gaps in care systems, variable access to prevention, diagnosis, and treatment.
  • "Through World Heart Day and the year-long #UseHeart movement, the World Heart Federation reaches more than 2 billion people every year.

Servier Targets Transformative Treatment of Cancer at ASCO 2023

Retrieved on: 
Thursday, May 25, 2023

BOSTON and PARIS, May 25, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will showcase new data across its robust oncology portfolio at the American Society of Clinical Oncology (ASCO) annual meeting June 2-6, 2023. These latest data, including a plenary session selection, underscore the breadth of Servier's oncology pipeline and portfolio and the company's commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.

Key Points: 
  • These latest data, including a plenary session selection, underscore the breadth of Servier's oncology pipeline and portfolio and the company's commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.
  • Among the data to be presented is a late breaking abstract featuring the results from the Phase 3 INDIGO study of vorasidenib in patients with residual or recurrent grade 2 IDH-mutant glioma.
  • "Servier is leading the scientific research with IDH inhibition across a variety of difficult to treat cancers, and this year at ASCO, we are excited to showcase data that has the potential to shift the treatment paradigm for patients with IDH-mutant glioma," said Susan Pandya, M.D., Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier.
  • Servier abstracts being presented at EHA are listed below (all times in Central European Summer Time) and are available online on the EHA website here .

Aitia Enters into Multi-Year AI-Driven Drug Discovery and Drug Simulation Collaboration with Servier for Pancreatic Cancer

Retrieved on: 
Wednesday, May 17, 2023

This is mainly due to the fact that pancreatic cancer patients are often diagnosed at stage IV, when the disease has metastasized3.

Key Points: 
  • This is mainly due to the fact that pancreatic cancer patients are often diagnosed at stage IV, when the disease has metastasized3.
  • Under the terms of the collaboration, Aitia and Servier will work together to focus on translational questions to discover, validate, and strive to develop novel drug targets and drug candidates in pancreatic cancer through utilization of Aitia's Pancreatic Cancer Digital Twins and Servier's pre-clinical assays, therapeutic creation platforms, and expertise.
  • Drug discovery and development efforts in pancreatic cancer to date have yielded very few treatment options for patients," said Colin Hill, CEO and co-founder of Aitia.
  • By leveraging Aitia's Gemini Digital Twins we're unlocking new opportunities for innovation and discovery in the field of pancreatic cancer drug research.

Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma

Retrieved on: 
Wednesday, May 10, 2023

It has received orphan medicine designation recognizing the significant benefit brought to patients by Tibsovo® over available therapies for both CCA and AML.

Key Points: 
  • It has received orphan medicine designation recognizing the significant benefit brought to patients by Tibsovo® over available therapies for both CCA and AML.
  • "The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options.
  • With today's approval by the European Commission, Tibsovo® is now the first targeted IDH1 inhibitor approved in Europe.
  • "IDH1 mutations are major drivers of disease progression in acute myeloid leukemia and cholangiocarcinoma, which are usually diagnosed at an advanced stage, highlighting the urgent need for a targeted therapeutic option.

Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma

Retrieved on: 
Wednesday, May 10, 2023

"The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options.

Key Points: 
  • "The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options.
  • With today's approval by the European Commission, Tibsovo® is now the first targeted IDH1 inhibitor approved in Europe.
  • "IDH1 mutations are major drivers of disease progression in acute myeloid leukemia and cholangiocarcinoma, which are usually diagnosed at an advanced stage, highlighting the urgent need for a targeted therapeutic option.
  • The European Commission's approval in cholangiocarcinoma is supported by data from the ClarIDHy trial, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma.