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Details:
Sarclisa (isatuximab) is a antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells. It is being evaluated in phase 3 clinical trials in combination with carfilzomib, lenalidomide & dexamethasone (KRd) for the treatment ofMultiple Myeloma.
Lead Product(s): Isatuximab,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Sarclisa
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2023
Iran Expo
Not Confirmed
Contact SupplierDetails:
Latest results from Phase 3 IKEMA clinical trial for Sarclisa®(isatuximab-irfc) in combination with carfilzomib and dexamethasone demonstrated a median PFS of 35.7 months, compared to 19.2 months in patients treated with Kd alone.
Lead Product(s): Isatuximab-irfc,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Sarclisa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2022
Iran Expo
Not Confirmed
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Details:
For the Sarclisa® subcutaneous formulation delivery, Sanofi has partnered with drug delivery technology innovator company to advance the development of a subcutaneous delivery for Sarclisa® with the goal of offering a unique patient-centric treatment experience.
Lead Product(s): Isatuximab,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Sarclisa
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Blackstone Life Sciences
Deal Size: $330.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration March 15, 2022
Iran Expo
Not Confirmed
Contact SupplierDetails:
SARCLISA® continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumours.
Lead Product(s): Isatuximab-irfc,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Sarclisa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Iran Expo
Not Confirmed
Contact SupplierDetails:
Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity.
Lead Product(s): Isatuximab-irfc,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Sarclisa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2021
Iran Expo
Not Confirmed
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The decision follows the Phase III IKEMA trial, which featured 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries. The study found that Sarclisa added to Kd reduced the risk of disease progression or death by 45%, versus Kd alone.
Lead Product(s): Isatuximab-irfc,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Sarclisa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Iran Expo
Not Confirmed
Contact SupplierDetails:
Sarclisa (isatuximab) has been recommended in combination with pomalidomide and dexamethasone in relapsed/refractory multiple myeloma who have received three prior lines of treatment, including lenalidomide and proteasome inhibitor.
Lead Product(s): Isatuximab-irfc,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Sarclisa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
SARCLISA™ in combination with pom-dex significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial.
Lead Product(s): Isatuximab,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Sarclisa
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
EC approval based on data from first randomized Phase 3 trial (ICARIA-MM) to report results evaluating an anti-CD38 monoclonal antibody combined with pomalidomide and dexamethasone (pom-dex).
Lead Product(s): Isatuximab,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
Positive CHMP opinion based on data from ICARIA-MM, the first randomized Phase 3 trial to evaluate an anti-CD38 in combination with pom-dex.
Lead Product(s): Isatuximab,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
The company intends to use the net proceeds to fund the development of CCS1477 (inobrodib), its p300/CBP inhibitor to treat specific types of cancer including haematological malignancies and multiple myeloma.
Lead Product(s): Inobrodib,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: CCS1477
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Financing July 11, 2023
Details:
TECVAYLI™ (Teclistamab-cqyv), is a first-in-class, bispecific T-cell engager antibody therapy which uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T cells and to the B-cell maturation antigen (BCMA).
Lead Product(s): Teclistamab-cqyv,Daratumumab,Pomalidomide
Therapeutic Area: Oncology Product Name: Tecvayli
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2022
Details:
Inobrodib (CCS1477) is a pioneering drug targeting twin tumour drivers p300/CBP, providing a new way to treat specific cancers, to treat late stage multiple myeloma patients.
Lead Product(s): Inobrodib,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: CCS1477
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2022
Details:
XPOVIO (selinexor) is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer.
Lead Product(s): Selinexor,Dexamethasone,Pomalidomide
Therapeutic Area: Oncology Product Name: Xpovio
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: European Myeloma Network
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2022
Details:
Subcutaneous daratumumab in combination with pomalidomide and dexamethasone reduced the risk of death or disease progression compared with pomalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma.
Lead Product(s): Daratumumab,Dexamethasone,Pomalidomide
Therapeutic Area: Oncology Product Name: Darzalex
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: European Myeloma Network
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2020
Details:
DARZALEX FASPRO® significantly reduced the risk of progression or death by 37 percent when added to Pd, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval).
Lead Product(s): Daratumumab,Hyaluronidase,Pomalidomide
Therapeutic Area: Oncology Product Name: Darzalex Faspro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 04, 2020
Details:
U.S. Food and Drug Administration has approved Breckenridge’s Abbreviated New Drug Application for Pomalidomide Capsules (generic for Pomalyst®).
Lead Product(s): Pomalidomide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Natco Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Updated Results from the Pomalyst®, Kyprolis® and Revlimid® Arms of the Phase 1b/2 STOMP Study Evaluating XPOVIO in Combination with Other Approved Myeloma Therapies in Relapsed or Refractory Multiple Myeloma to be Presented.
Lead Product(s): Selinexor,Dexamethasone,Pomalidomide
Therapeutic Area: Oncology Product Name: Xpovio
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
Phase 3 APOLLO randomized study evaluating subcutaneous daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in relapsed or refractory multiple myeloma met the primary endpoint of improving progression-free survival.
Lead Product(s): Daratumumab,Pomalidomide,Dexamethasone
Therapeutic Area: Oncology Product Name: Darzalex
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2020
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