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Details:
Enhertu (trastuzumab deruxtecan) is a HER2-directed antibody-drug conjugate which is being evaluated in phase 3 clinical trials for the treatment of patients with unresectable or metastatic HER2-expressing advanced solid tumours.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2024
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate and received EU approval for Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2023
Details:
Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC, which has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2023
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate and received two additional Breakthrough Therapy Designations (BTDs) in the U.S. for the treatment of HER2 positive solid tumors.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2023
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate and approved in Japan as first HER2 directed therapy for patients with HER2 mutant metastatic non-small cell lung cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2023
Details:
ENHERTU (Trastuzumab deruxtecan) is a HER2 directed antibody drug conjugate (ADC) attached to a topoisomerase I inhibitor payload, via a stable tetrapeptide-based cleavable linker, being developed for multiple HER2-expressing advanced solid tumours.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2023
Details:
ENHERTU (Trastuzumab deruxtecan) is a HER2 directed antibody drug conjugate (ADC) attached to a topoisomerase I inhibitor payload, via a stable tetrapeptide-based cleavable linker. Drug is used as a HER2 Low Metastatic Breast Cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
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 12, 2023
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate. Company has received approval from the DCGI to import the cancer drug trastuzumab deruxtecan used for the treatment of metastatic breast cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2023
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate. It binds to HER2 on tumor cells and undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Thus causing DNA damage and apoptotic cell death.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: ENHERTU
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2023
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate. It binds to HER2 on tumor cells and undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Thus causing DNA damage and apoptotic cell death.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2023
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate. It binds to HER2 on tumor cells and undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Thus causing DNA damage and apoptotic cell death.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2023
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate. It binds to HER2 on tumor cells and undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Thus causing DNA damage and apoptotic cell death.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2023
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody-drug conjugate. It binds to HER2 on tumor cells and undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Thus causing DNA damage and apoptotic cell death.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2023
Details:
ENHERTU (Trastuzumab deruxtecan) is a HER2 directed antibody drug conjugate (ADC) attached to a topoisomerase I inhibitor payload, via a stable tetrapeptide-based cleavable linker. Drug is used as a monotherapy for treating non-small cell lung cancer in adult patients .
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: ENHERTU
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
Enhertu (fam-trastuzumab deruxtecan-nxki) is a specifically engineered HER2-directed antibody drug conjugate (ADC). In the trial, Enhertu reduced the risk of disease progression or death by 50% versus physician’s choice of chemotherapy of 0.50; 95% confidence interval.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed antibody drug conjugate (ADC). ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
Updated results from trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated significant and clinical improvement in OS compared to trastuzumab emtansine in patients with HER2 breast cancer previously treated with trastuzumab and a taxane.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed antibody drug conjugate (ADC). ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
INB03™ is a Dominant Negative Tumor Necrosis Factor (DN-TNF) inhibitor that neutralizes soluble TNF (sTNF) without affecting trans membrane TNF (tmTNF) or TNF receptors.
Lead Product(s): INB03,Deruxtecan
Therapeutic Area: Oncology Product Name: INB03
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2022
Details:
Enhertu (trastuzumab deruxtecan, fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC,consists of HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2022
Details:
Based on DESTINY-Gastric02 which showed AstraZeneca and Daiichi Sankyo’s Enhertu (Fam-Trastuzumab Deruxtecan-nxki) demonstrated clinically meaningful efficacy and DESTINY-Gastric01 which showed improved overall survival compared to chemotherapy.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
PATHWAY anti-HER2 test is only FDA approved companion diagnostic indicated as an aid in assessment of HER2 low status in metastatic breast cancer patients, who may consider ENHERTU (fam-trastuzumab deruxtecan-nxki) as a treatment option based on results of Phase 3 trial.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2022
Details:
DESTINY-Lung02 phase 2 trial shows clinically meaningful efficacy and favorable safety at 5.4 mg/kg dose versus 6.4 mg/kg dose of Daiichi Sankyo and AstraZeneca’s Enhertu (Trastuzumab Deruxtecan) in HER2 mutant disease.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2022
Details:
DESTINY-Lung02 Phase II trial shows clinically meaningful efficacy and favourable safety at 5.4mg/kg vs. 6.4mg/kg dose of AstraZeneca and Daiichi Sankyo’s Enhertu (Trastuzumab Deruxtecan) in HER2-mutant disease.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2022
Details:
Positive high-level results from trial of Enhertu (trastuzumab deruxtecan) versus physician’s choice of treatment showed the trial met primary endpoint, demonstrating statistically significant and clinically meaningful improvement in PFS in patients with HER2-breast cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2022
Details:
The topline results from DESTINY-Breast02 confirm the progression-free survival seen in previous trials of ENHERTU (Trastuzumab Deruxtecan) and enrich our clinical understanding of the benefit this therapy may offer patients with HER2 positive metastatic breast cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2022
Details:
The lead product candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain.
Lead Product(s): Evorpacept,Deruxtecan
Therapeutic Area: Oncology Product Name: ALX148
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Quantum Leap Healthcare
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2022
Details:
Accelerated approval by FDA was based on results from trial showed that ENHERTU (5.4 mg/kg/trastuzumab deruxtecan) demonstrated confirmed ORR of 57.7% in patients with HER2 mutant NSCLC who had received one prior systemic therapy.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2022
Details:
Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s ENHERTU (fam-trastuzumab deruxtecan-nxki) reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2022
Details:
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2022
Details:
Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2022
Details:
ENHERTU (famtrastuzumab deruxtecan-nxki), is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
Based on ground-breaking DESTINY-Breast03 results in which Enhertu (trastuzumab deruxtecan) demonstrated a 72% reduction in the risk of disease progression or death vs. trastuzumab emtansine (T-DM1).
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
Based on groundbreaking DESTINY-Breast03 results in which ENHERTU demonstrated a 72% reduction in the risk of disease progression or death vs. trastuzumab emtansine (T-DM1).
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
Recommendation based on DESTINY-Breast03 trial results showing AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1).
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Submission based on DESTINY-Breast04 results that showed DS-8201 (trastuzumab deruxtecan) demonstrated superior progression-free survival and overall survival versus chemotherapy.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: DS-8201
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 June 27, 2022
Details:
Recommendation based on DESTINY-Breast03 trial results showing DS-8201 (trastuzumab deruxtecan) reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1).
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: DS-8201
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Application based on DESTINY-Breast04 results that showed Enhertu (trastuzumab deruxtecan), a HER2 directed ADC demonstrated superior progression-free and overall survival versus chemotherapy.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
ENHERTU (Trastuzumab deruxtecan) met the primary endpoint of progression free survival in patients with HR positive disease, reducing the risk of disease progression or death by 49% vs. chemotherapy.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2022
Details:
Enhertu (Fam-Trastuzumab Deruxtecan-nxki) met the primary endpoint of progression-free survival in patients with HR-positive disease, reducing the risk of disease progression or death by 49% vs. chemotherapy.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2022
Details:
Enhertu (Fam-Trastuzumab Deruxtecan-nxki) data will show the potential to improve survival for metastatic breast cancer patients and define a new segment of HER2-low disease.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
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 23, 2022
Details:
Presentations, including a Plenary Session at ASCO featuring the DESTINY-Breast04 trial of ENHERTU® (trastuzumab deruxtecan) and at EHA (S100) highlighting the QuANTUM-First trial of quizartinib, underscore the leadership in developing multiple transformative medicines.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
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 23, 2022
Details:
Approval by FDA was based on positive results from DESTINY-Breast03 Phase III trial that showed Enhertu (trastuzumab deruxtecan) reduced risk of disease progression or death by 72% versus trastuzumab emtansine in patients with HER2 metastatic breast cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
The FDA granted the BTD Based on DESTINY-Breast04 results where Daiichi Sankyo and AstraZeneca’s ENHERTU demonstrated significant improvement in both progression-free survival and overall survival.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a significant improvement in both progression-free survival and overall survival.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
Primary results from previously-treated patients with HER2-mutations of DESTINY-Lung01 demonstrated a confirmed objective response rate of 54.9% in patients treated with Enhertu (6.4mg/kg) as assessed by independent central review.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
The results of DESTINY-Lung-01 showed that ENHERTU is the first HER2 directed therapy to demonstrate a strong and robust tumor response in more than half of patients with previously treated HER2 2 mutant metastatic non-small cell lung cancer.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
DESTINY-Breast04 met its primary endpoint, where Enhertu demonstrated superior PFS in previously treated patients with HR-positive HER2-low metastatic breast cancer compared to the standard-of-care chemotherapy.
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2022
Details:
Based on groundbreaking DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s ENHERTU reduced the risk of disease progression or death by 72% versus ado-trastuzumab emtansine (T-DM1).
Lead Product(s): Deruxtecan
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2022
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