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Details:
CS1003 (nofazinlimab) is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1) being developed in combination with lenvatinib as first-line treatment for patients with advanced hepatocellular carcinoma.
Lead Product(s): Nofazinlimab,Lenvatinib Mesylate
Therapeutic Area: Oncology Product Name: CS1003
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 March 18, 2022
Details:
MHLW has approved the combination of LENVIMA (lenvatinib) multiple receptor tyrosine kinase inhibitor Plus KEYTRUDA® (pembrolizumab) anti-PD-1 therapy for the treatment of patients with endometrial carcinoma.
Lead Product(s): Lenvatinib Mesylate,Pembrolizumab
Therapeutic Area: Oncology Product Name: Lenvima
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 24, 2021
Details:
KEYTRUDA plus LENVIMA is the first anti-PD-1 and tyrosine kinase inhibitor combination to demonstrate a survival benefit in advanced endometrial carcinoma patients, and the benefit was shown regardless of mismatch repair status.
Lead Product(s): Lenvatinib Mesylate,Pembrolizumab
Therapeutic Area: Oncology Product Name: Lenvima
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2021
Details:
In this trial, LENVIMA plus KEYTRUDA showed a statistically significant and clinically meaningful improvement in the primary endpoints of Progression-Free Survival and Overall Survival as well as the secondary endpoint of Objective Response Rate versus chemotherapy.
Lead Product(s): Lenvatinib Mesylate,Pembrolizumab
Therapeutic Area: Oncology Product Name: Lenvima
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 23, 2021
Details:
The application requesting an indication of lenvatinib in combination with pembrolizumab for RCC is based on the results of the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581) for the first-line treatment of patients with advanced RCC.
Lead Product(s): Lenvatinib Mesylate,Pembrolizumab
Therapeutic Area: Oncology Product Name: Lenvima
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2021
Details:
The pivotal Phase 3 Study 309/KEYNOTE-775 evaluated LENVIMA in combination with KEYTRUDA® in patients with advanced endometrial cancer, following at least one prior platinum-based regimen in Japan, the United States, Europe and other countries.
Lead Product(s): Lenvatinib Mesylate,Pembrolizumab
Therapeutic Area: Oncology Product Name: Lenvima
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 15, 2021
Details:
Bdfoie (lenvatinib mesylate), an oral receptor tyrosine kinase inhibitor, launched in India, for the treatment of differentiated thyroid cancer, advanced liver cancer and advanced kidney cancer.
Lead Product(s): Lenvatinib Mesylate
Therapeutic Area: Oncology Product Name: Bdfoie
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 21, 2020