Ivosidenib

Servier Showcases Leadership in Mutant Isocitrate Dehydrogenase (IDH) Inhibition Through New Data Spotlighting Real-World Treatment Patterns and Clinical Outcomes of Tibsovo® Use at ASH 2023

Retrieved on: 
Saturday, December 9, 2023
Human, Research, PST, FN, Toxicity, Incidence, ASH, Commercial, Acute myeloid leukemia, Syndrome, Hematology, HMA, Febrile neutropenia, Patient, MRD, Science, Exposition, MDS, IDH, IDH1, Diagnosis, Chondrosarcoma, CCA, AML, Doctor of Philosophy, Cancer, Society, Mutation, ALL, Health, Pharmaceutical industry, Ivosidenib, Medicine

BOSTON, Dec. 9, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will be presenting new data in acute myeloid leukemia (AML) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. These data provide a compelling and in-depth look into the treatment patterns and clinical outcomes observed in real-world settings, offering valuable insights for informed decision-making in patient care.

Key Points: 
  • These data provide a compelling and in-depth look into the treatment patterns and clinical outcomes observed in real-world settings, offering valuable insights for informed decision-making in patient care.
  • In the analysis of 238 patients, Tibsovo+HMA elicited a higher complete response (CR) rate versus venetoclax+HMA at 42.9% vs. 26.7% (p=0.007).
  • Median time from diagnosis to start of treatment was 14 versus 20 days for Tibsovo+HMA vs venetoclax+HMA.
  • "At Servier, we bring the patient voice into everything we do, and our commitment to patients extends far beyond approval," emphasized Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals.

Servier Data at ASH 2023 Furthers Leadership in Hard-to-Treat Hematologic Malignancies

Retrieved on: 
Tuesday, December 5, 2023
Real-World Evidence, Azacitidine, Safety, PST, University, ASH, Acute myeloid leukemia, Comparison, Tablet, HMA, Hematology, Patient, Poster, MRD, FDA, Master of Science, Acute lymphoblastic leukemia, MDS, IDH, IDH1, Venetoclax, AML, Doctor of Philosophy, MD Anderson Cancer Center, Society, Mutation, Adolescence, ALL, Acute leukemia, Pharmaceutical industry, Nursing, Medical imaging, Ivosidenib, Medicine

BOSTON, Dec. 5, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will present data in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12, 2023. The latest data underscores Servier's commitment to advancing scientific research, including gaining a more robust understanding of real-world treatment patterns for patients with difficult and hard-to-treat cancers.

Key Points: 
  • The latest data underscores Servier's commitment to advancing scientific research, including gaining a more robust understanding of real-world treatment patterns for patients with difficult and hard-to-treat cancers.
  • "ASH is a tremendous opportunity to connect with the broader hematologic community and share scientific advances with the power to improve the treatment landscape for patients in need of innovation," said David K. Lee, CEO, Servier Pharmaceuticals.
  • "Looking to the future, improving patient outcomes is going to be a collaborative effort across industry, academia and the community.
  • Servier is proud to serve as a bridge across these stakeholders in our goal of improving patient outcomes."

Chondrosarcoma Market Outlook to 2032: Emerging Therapies and Market Access Drive Growth in the 7MM, Addressing Unmet Needs in Rare Bone Cancer Treatment - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 9, 2023
Health, Oncology, TKI, EU4, Ivosidenib, Disease, Radiation, Chondrosarcoma, USD, NCCN, Patient, IDH2, IDH1, United Kingdom, Dasatinib, Drug pipeline, Pharmaceutical industry, Epidemiology

It also includes insights from key opinion leaders, pipeline activities, and market access and reimbursement scenarios for chondrosarcoma therapies.

Key Points: 
  • It also includes insights from key opinion leaders, pipeline activities, and market access and reimbursement scenarios for chondrosarcoma therapies.
  • Chondrosarcoma Cases and Market Size: As per NCCN Guidelines, nearly 65% of chondrosarcoma cases are related to IDH1 or IDH2 mutations.
  • Limited Treatment Options: Conventional chondrosarcomas, the major subtype, are considered resistant to chemotherapy and radiation, resulting in limited treatment options.
  • Market Access and Reimbursement: Reimbursement of rare disease therapies like chondrosarcoma can be limited due to high costs and lack of specific approaches to evaluating rare disease drugs.

Wren Taps Vertex Veteran Executives and Other Leaders to Advance First-in-Class Small-Molecule Drugs into Clinical Testing for Neurodegenerative Diseases

Retrieved on: 
Thursday, December 8, 2022
Novartis Institute for Tropical Diseases, Therapy, Degenerative disease, Friedreich's ataxia, Neurodegeneration, Thomson, Biomedical Research, Agios Pharmaceuticals, NDA, Alzheimer's disease, Sickle cell disease, Doctor of Philosophy, Drug discovery, Biophysics, Research, Hepatitis, Science, Ideation, IEEE Corporate Innovation Recognition, Schering-Plough, Autism, Vertex, Huntington's disease, FDA, Drug development, Pharmaceutical Development and Technology, ALS, NIBR, Endocrinology, Vertex Pharmaceuticals, Human, Translation, Senior, Connelly, Head, Hepatitis C, Inflammation, Parkinson's disease, Decibel, Cystic fibrosis, Ipsen, Fine chemical, Pharmaceutical industry, Management, Chemistry, Wren, Ivosidenib, EU, Sanofi, DRS

BOSTON, Dec. 8, 2022 /PRNewswire/ -- Wren Therapeutics announced today a number of senior leadership appointments as the company advances its first investigational therapies toward the clinic, based on the company's breakthrough approach to discovering small molecules that precisely target and shut down the sources of oligomer and aggregate generation in neurodegenerative diseases.

Key Points: 
  • The company recently welcomed Vertex Pharmaceuticals veterans John Thomson, PhD and Patrick Connelly, PhD as its Chief Scientific Officer and first Chief Innovation Officer, respectively.
  • Dr. Thomson and Dr. Connelly are Vertex founding scientists who worked together on leadership teams that discovered and developed Vertex's seven FDA-approved drugs.
  • "We couldn't be more pleased to welcome John, Pat, Mike, Janeta, and Rajeev to Wren's teamall proven executives in their fields.
  • With this lineup of experienced talent, Wren has the leadership team to break open the field of neurodegenerative diseases targeting the molecular mechanisms at the source of toxic oligomer generation."

Nuvalent Announces Leadership Promotions

Retrieved on: 
Wednesday, July 20, 2022
Chemistry, Duvelisib, View, Pharmaceutical Development and Technology, Biogen, Degenerative disease, U.S. Securities and Exchange Commission, Twitter, Hematology, Alpha-galactosidase, IND World's Fair Line, Research, HER2, Risk, Private Securities Litigation Reform Act, Government, Merck Serono, Brain, COVID-19, Multimedia, Cancer, Leadership, Quality assurance, Agios, Merck, Drug development, NSCLC, Company, Senior, Security (finance), Texas A&M University, LinkedIn, Patient, Nasdaq, ALK, Therapy, Neurology, Sanofi, Annual report, LLC, Columbia University, Harvard University, Management, Pharmaceutical industry, Architecture, Genzyme, Ivosidenib, Avelumab, Plerixafor, Infinity

CAMBRIDGE, Mass., July 20, 2022 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced two leadership team promotions. Darlene Noci, A.L.M. has been promoted to Chief Development Officer and will continue to oversee all global Product Development and Regulatory Affairs activities. Benjamin Lane, Ph.D. has been promoted to Senior Vice President, Technical Operations and will continue to oversee all Pharmaceutical Development and Quality Assurance activities.

Key Points: 
  • Benjamin Lane, Ph.D. promoted to Senior Vice President, Technical Operations
    CAMBRIDGE, Mass., July 20, 2022 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creatingpreciselytargeted therapies for clinically proven kinase targets in cancer, today announced two leadership team promotions.
  • Prior to joining Nuvalent, Ms. Noci held various regulatory, quality assurance and global development team leadership positions with increasing responsibility at X4 Pharmaceuticals, EMD Serono, Infinity, Sanofi, and Genzyme.
  • "These promotions reflect the significant contributions made by Darlene and Ben in establishing Nuvalent as a clinical-stage company with strong expertise in the development of novel oncology therapies," said James Porter, Ph.D., Chief Executive Officer at Nuvalent.
  • We routinely post information that may be important to investors on our website at www.nuvalent.com .Follow us on Twitter ( @nuvalent ) and LinkedIn .

Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO® (ivosidenib tablets) in IDH1-mutated Cholangiocarcinoma

Retrieved on: 
Wednesday, May 5, 2021
Medicine, Clinical medicine, IDH1, Cancer, Cholangiocarcinoma, Priority review, Food and Drug Administration, Orphan drugs, Antineoplastic drugs, Ivosidenib

"\nThe sNDA acceptance is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma.

Key Points: 
  • "\nThe sNDA acceptance is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma.
  • "The FDA\'s Priority Review is a major milestone for patients.
  • There are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available in the advanced setting.
  • Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval.

Agios Submits Supplemental New Drug Application to FDA for TIBSOVO® (ivosidenib tablets) for Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma

Retrieved on: 
Monday, March 1, 2021
Cancer, Clinical medicine, Medicine, Antineoplastic drugs, Orphan drugs, Acute myeloid leukemia, Ivosidenib, Oncology, Cholangiocarcinoma, IDH1, Chemotherapy

Agios has requested priority review for the application, which, if granted, could result in a six-month review process.

Key Points: 
  • Agios has requested priority review for the application, which, if granted, could result in a six-month review process.
  • The sNDA submission is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma.
  • There are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available in the advanced setting.
  • Patients treated with TIBSOVOhave experienced symptoms of differentiation syndrome, which can be fatal if not treated.

Agios Presents Final Data from Phase 3 ClarIDHy Study of TIBSOVO® (ivosidenib tablets) in Patients with Previously Treated IDH1-Mutant Cholangiocarcinoma

Retrieved on: 
Sunday, January 17, 2021
Clinical research, Health, Medicine, Clinical medicine, Design of experiments, Orphan drugs, Cholangiocarcinoma, Hepatology, Blinded experiment, Ivosidenib, Placebo

The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.

Key Points: 
  • The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.
  • As of the May 31, 2020 data cutoff, 187 patients were randomized, with 126 patients in the TIBSOVO arm and 61 patients in the placebo arm.
  • Forty-three patients randomized to placebo (70.5%) crossed over to open-label TIBSOVO upon radiographic disease progression and unblinding.
  • Agios plans to submit a supplemental new drug application for TIBSOVO in previously treated IDH1-mutant cholangiocarcinoma in the first quarter of 2021.

APL-106 (uproleselan) Granted Breakthrough Therapy Designation in China for the Treatment of Acute Myeloid Leukemia

Cancer treatments, Acute myeloid leukemia, Leukemia, 7+3, Clinical medicine, Chemotherapy, Antibody-drug conjugates, CD135, Ivosidenib

Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin.

Key Points: 
  • Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin.
  • In 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML.
  • Apollomics licensed APL-106 from GlycoMimetics in January 2020 to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.
  • Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow.

Agios Announces Withdrawal of European Marketing Authorization Application for TIBSOVO® as a Treatment for Relapsed or Refractory IDH1-mutant Acute Myeloid Leukemia

Retrieved on: 
Friday, October 16, 2020
Acute myeloid leukemia, Cancer, Orphan drugs, Drugs, Ivosidenib, RTT, 7+3, Antibody-drug conjugates, CD135

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated.

Key Points: 
  • Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated.
  • In the clinical trial, 25% (7/28) of patients with newly diagnosed AML and 19% (34/179) of patients with relapsed or refractory AML treated with TIBSOVO experienced differentiation syndrome.
  • Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated.
  • Of the 34 patients with relapsed or refractory AML who experienced differentiation syndrome, 27 (79%) patients recovered after treatment or after dose interruption of TIBSOVO.