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Lead Product(s): Enfortumab vedotin-ejfv
Therapeutic Area: Oncology Product Name: Padcev
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Seagen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2021
Details:
The sBLA for regular approval of PADCEV in the U.S. is supported by data from the global EV-301 phase 3 confirmatory trial, which compared PADCEV to chemotherapy in metastatic urothelial cancer, previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
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Lead Product(s): Trastuzumab Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca PLC
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2021
Details:
Authorisation is based on the results of the single arm, phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan (5.4 mg/kg) in 184 patients with HER2 positive metastatic breast cancer.
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Lead Product(s): Leuprolide Acetate,Tamoxifen Citrate
Therapeutic Area: Oncology Product Name: PROSTAP 3 DCS
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2021
Details:
The Scottish Medicines Consortium has accepted Takeda’s PROSTAP 3 DCS (leuprorelin acetate) treatment for use in patients with early and advanced breast cancer, which is the most common cancer in women globally.
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Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: Approved Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2021
Details:
The approval of YESCARTA in Japan is based on ZUMA-1 trial conducted by Kite and results of a phase 2 study conducted by Daiichi Sankyo in Japan. The overall safety and tolerability profile of YESCARTA in the Japan trial was consistent with that observed in ZUMA-1.
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Lead Product(s): Brigatinib
Therapeutic Area: Oncology Product Name: Alunbrig
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2021
Details:
Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market “ALUNBRIG® Tablets 30 mg, 90 mg" as a first and second-line therapy for patients with unresectable, advanced or recurrent ALK+ NSCLC.
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Lead Product(s): Trastuzumab Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca PLC
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
The US FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen. Approval was based on DESTINY-Gastric01 study.
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Lead Product(s): Atezolizumab
Therapeutic Area: Oncology Product Name: Tecentriq
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable Decembe
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