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Details:
Tibsovo (ivosidenib) tablet is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 enzyme, which is investigated for IDH1-mutated Relapsed or refractory myelodysplastic syndromes.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2023
Details:
TIBSOVO® (ivosidenib) tablet is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 enzyme, which is investigated for IDH1-mutated Relapsed or refractory myelodysplastic syndromes.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2023
Details:
Tibsovo® (ivosidenib tablets) is the first and only IDH1 inhibitor approved in Europe. It has received orphan medicine designation recognizing the significant benefit brought to patients by Tibsovo® over available therapies for both CCA and AML.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Details:
Tibsovo (ivosidenib) is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. In patients with AML, susceptible IDH1 mutations are defined as those leading to increased levels of 2-hydroxyglutarate (2-HG) in the leukemia cells.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2023
Details:
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with Newly Diagnosed Acute Myeloid Leukemia (AML) susceptible IDH1 mutation.
Lead Product(s): Ivosidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
TIBSOVO® (ivosidenib) is an oral, targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with an isocitrate dehydrogenase-1 (IDH1) mutation with acute myeloid leukemia (AML) or cholangiocarcinoma (bile duct cancer).
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sagard Healthcare Partners
Deal Size: $131.8 million Upfront Cash: Undisclosed
Deal Type: Agreement October 27, 2022
Details:
TIBSOVO® (ivosidenib), which is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with newly diagnosed acute myeloid leukemia (AML).
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Servier
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2022
Details:
Through this collaboration, Servier has worked with Mission Bio’s Pharma Assay Development services to utilize Tapestri single-cell DNA sequencing technology to serially assess hundreds of samples with IDH1-mutated AML who have been treated with TIBSOVO (ivosidenib).
Lead Product(s): Ivosidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mission Bio
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2022
Details:
Global Phase 3 trial of TIBSOVO met its primary endpoint of event-free survival and all key secondary endpoints, complete remission rate, overall survival, complete remission and complete remission with partial hematologic recovery rate and objective response rate.
Lead Product(s): Ivosidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2022
Details:
sNDA is based on data from AGILE trial demonstrate improved event-free survival and overall survival of TIBSOVO, the first therapy targeting cancer metabolism in combination with azacitidine in previously untreated IDH1-mutated acute myeloid leukemia.
Lead Product(s): Ivosidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
Details:
Treatment with TIBSOVO in combination with azacitidine compared to azacitidine in combination with placebo demonstrated a statistically significant improvement in EFS.
Lead Product(s): Ivosidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 02, 2021
Details:
The transaction includes the transfer to Servier of Agios Pharmaceuticals’ oncology portfolio, development pipeline and research programs, notably, TIBSOVO (ivosidenib), IDHIFA (enasidenib), Vorasidenib and AG-270.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Servier
Deal Size: $2,000.0 million Upfront Cash: $1,800.0 million
Deal Type: Acquisition April 01, 2021
Details:
Agios has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for TIBSOVO® (ivosidenib tablets) as a potential treatment for patients with previously treated isocitrate dehydrogenase 1 (IDH1) mutated cholangiocarcinoma.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2021
Details:
The final analysis showed an improvement in the secondary endpoint of OS favoring patients randomized to TIBSOVO® compared to those randomized to placebo; however, statistical significance was not reached.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: TIBSOVO
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2021
Details:
Ivosidenib, an oral, targeted inhibitor of the IDH1 enzyme, is globally the first and only US FDA-approved therapy for patients with R/R AML and an IDH1 mutation. Ivosidenib was developed by Agios Pharmaceuticals.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Agios Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2020
Details:
Abstract titled "Ivosidenib Improves Overall Survival Relative to Standard Therapies in Relapsed or Refractory Mutant IDH1 AML: Results from Matched Comparisons to Historical Controls" will be presented at the Virtual 2020 ASH Annual Meeting.
Lead Product(s): Ivosidenib,Azacitidine
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
A consistent trend in improved OS was observed in patients treated with TIBSOVO® compared to those randomized to placebo, but was not statistically significant.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Tibsovo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
The study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) in patients randomized to TIBSOVO® compared with placebo patients.
Lead Product(s): Ivosidenib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2020
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