All Data
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Lead Product(s): Durvalumab
Therapeutic Area: Oncology Product Name: Imfinzi
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 January 15, 2021
Details:
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer.
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Lead Product(s): Olaparib,Bevacizumab
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co. Inc.
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 28, 2020
Details:
Approvals of Lynparza in Three Types of Cancer are based on the PAOLA-1, PROfound and POLO Phase 3 Trials , which each were published in The New England Journal of Medicine.
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Lead Product(s): Osimertinib Mesylate
Therapeutic Area: Oncology Product Name: Tagrisso
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 December 21, 2020
Details:
The approval based on ADAURA Phase III trial where Tagrisso showed a statistically significant and clinically meaningful improvement in disease-free survival in patients with Stage II and IIIA EGFRm NSCLC, andoverall trial population of patients with Stage IB-IIIA disease.
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Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
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 December 07, 2020
Details:
Pooled analysis of cardiovascular safety data from 762 patients treated with Calquence for chronic lymphocytic leukaemia, the most common type of adult leukaemia, across four clinical trials showed a low incidence of cardiac adverse events leading to discontinuation.
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Lead Product(s): Durvalumab,Tremelimumab
Therapeutic Area: Oncology Product Name: Imfinzi
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 November 20, 2020
Details:
This new option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.
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Lead Product(s): Acalabrutinib
Therapeutic Area: Oncology Product Name: Calquence
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 November 09, 2020
Details:
Calquence demonstrated superior progression-free survival and favorable tolerability in both previously untreated and relapsed or refractory patients.
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Lead Product(s): Olaparib,Bevacizumab
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co. Inc.
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. 17.7 months with bevacizumab alone.
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Lead Product(s): Niraparib Tosylate
Therapeutic Area: Oncology Product Name: Zejula
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 October 29, 2020
Details:
Zejula is the first PARP inhibitor approved as monotherapy in the European Union for patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status.
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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: Daiichi Sankyo Co Ltd
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental biologics licence application from the FDA, in addition to the priority review, for the treatment of HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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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: Daiichi Sankyo Co Ltd
Deal Size: Not Available Upfront Cash: Not Available
Deal Type: Not Available October 28, 2020
Details:
The sBLA is based on results from the DESTINY-Gastric01 randomized Phase II trial, which showed significant and clinically meaningful improvement in objective response rate, the primary endpoint, and overall survival in patients treated with ENHERTU versus chemotherapy.
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