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<![CDATA[T-DXd Earns FDA Priority Review in First-Line HER2+ Breast Cancer]]>
24 Sep 2025 21:29 GMT
… cancer.1
The Prescription Drug User Fee Act target … .
“The DESTINY-Breast09 trial showed that treating patients with … with a taxane plus trastuzumab (Herceptin) and pertuzumab (THP; HR … individual agent. Any-grade treatment-emergent adverse effects (TEAEs) …
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<![CDATA[The FDA Grants Priority Review to T-DXd/Pertuzumab in 1L Metastatic Breast Cancer]]>
24 Sep 2025 17:03 GMT
… in July 2025, the FDA granted breakthrough therapy designation to … phase 3 DESTINY-Breast09 trial (NCT04784715), which evaluated … of a taxane, trastuzumab (Herceptin), and pertuzumab (n = 387 … treatment-related.
AEs of special interest were adjudicated drug- …
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<![CDATA[FDA Grants Priority Review to First-Line T-DXd Plus Pertuzumab in Metastatic HER2+ Breast Cancer]]>
24 Sep 2025 18:24 GMT
… cancer.1
The Prescription Drug User Fee Act target … with a taxane plus trastuzumab (Herceptin) and pertuzumab (THP; n = … , in July 2025, the FDA granted breakthrough therapy designation to … treatment option.”
What Was the Design of the DESTINY-Breast09 Trial …
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<![CDATA[Hercessi, Biosimilar to Herceptin, Shows Favorable Efficacy, Safety in Treating HER2+ MBC in Real-World Setting ]]>
24 Sep 2025 18:10 GMT
… trastuzumab is an FDA-approved antineoplastic biologic … product, Herceptin, to the biosimilar during treatment.1
Patients … a large-scale clinical trial with multicenter cooperation. … on the coadministered drugs, such as adjunctive medications, target therapy …
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Glenmark strikes $1 Bn cancer drug licensing deal with Chinese drugmaker
24 Sep 2025 16:53 GMT
… therapy, currently approved for the treatment of HER2-positive cancers, such … engineered to bind the HER2 (Herceptin) protein to inhibit its pairing … as Jiangsu Hengrui Pharmaceuticals, is one of China’s leading drugmakers and a …
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<![CDATA[First-Line Enhertu Combo Gets Priority Review in HER2+ Metastatic Breast Cancer]]>
25 Sep 2025 02:38 GMT
The U.S. Food and Drug Administration (FDA) has granted priority review to … medical need.
Phase 3 DESTINY-Breast09 Trial Results Showed Improved Outcomes
The FDA … the current standard treatment of a taxane chemotherapy, Herceptin (trastuzumab), and Perjeta …
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<![CDATA[New T-DXd Data Have the Potential to Reorder ADC Sequencing in HER2+ Breast Cancer]]>
22 Sep 2025 13:20 GMT
… or docetaxel plus trastuzumab (Herceptin) and pertuzumab (THP; n … for adjuvant treatment, holding an FDA approval in … is the chief medical officer of the International … #47;www.fda.gov/drugs/;resources-information-approved-drugs/fda-approves-ado- …
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<![CDATA[Breast Cancer Experts: Key ADC Developments and CDK 4/6 Inhibitor Updates Set to Dominate ESMO 2025]]>
25 Sep 2025 16:11 GMT
… or sequenced with trastuzumab [Herceptin], pertuzumab [Perjeta], and … phase 3 monarchE trial [NCT03155997] trial looking at endocrine … the crux of TNBC treatment, not checkpoint inhibition. … been underreported in clinical trials, making real-world …
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Israel Cancer Research Fund Partners with The Mark Foundation for Cancer Research to Support Lung Cancer Project Grant at Weizmann Institute of Science
25 Sep 2025 13:48 GMT
…
To address this recurring drug resistance, Prof. Yarden and … s approach to tackling drug resistance with bispecific antibodies … Genentech, where he developed Herceptin, a targeted therapy for … cancer prevention, diagnosis, and treatment. Since 2017, The Mark …
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India's missed shot, world is winning race for cancer cures
24 Sep 2025 03:05 GMT
… treatment remains challenging.
Identifying the gap
Although India's pharmaceutical … trial infrastructure are essential for drug development … breakthrough products like Herceptin (monoclonal antibody … participant, as cancer medications become more readily …
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