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Enhertu and Trodelvy Show Promise for First-Line Metastatic Breast Cancer Treatment
01 Aug 2025 02:01 GMT
… cancer. The Food and Drug Administration (FDA) initially approved Enhertu … taxane chemotherapy plus Herceptin and Perjeta. This treatment, known as … . “The DESTINY-Breast09 trial has the potential to … this type of treatment. This trial enrolled 443 patients …
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Roche Korea wins approval for breast cancer drug targeting PIK3CA-mutated HR+ HER2- patients
30 Jul 2025 07:41 GMT
… the HER2-positive space with drugs like Herceptin and Perjeta.
Itovebi is … inhibitors must have completed that treatment more than 12 months prior … on the phase 3 INAVO120 trial, which enrolled 325 patients whose …
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Postmarketing Surveillance Data Reinforce Trastuzumab Biosimilar Safety in HER2+ Gastric Cancer
06 Aug 2025 11:37 GMT
… product (Herceptin) was first approved by the US FDA in 1998 … extrapolation from a clinical trial on HER2-positive breast … that observed in the clinical trials.”
The objective response rate … seven (4%) completed the planned treatment, and eight (5%) underwent …
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Breast Cancer Treatment Transformed With HER2 Identification: Michael Hassett, MD, MPH
25 Jul 2025 12:20 GMT
… associate professor of medicine at Harvard Medical School.
In the … Institute for Value-Based Medicine® event in Boston, … identification on breast cancer treatment, highlighting how the biomarker … the first clinical trial data for trastuzumab (Herceptin) at the …
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Pooled Trial Data Highlight Potential of a Novel Biparatopic ADC in Heavily Pretreated HER2+ Breast Cancer
19 Jul 2025 17:46 GMT
… biparatopic HER2-targeting antibody-drug conjugate (ADC) … Regarding safety, any-grade treatment-emergent adverse effects (TEAEs … Herceptin],” lead study author Yiqun Du, MD, of the Department of Medical …
JSKN003 Background and Trial Overviews
The biparatopic …
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T-DXd Granted Breakthrough Therapy Designation by FDA in HER2+ Breast Cancer
18 Jul 2025 21:11 GMT
… news release from the drug’s developer, Daiichi-Sankyo … the phase 3 DESTINY-Breast09 trial (NCT04784715), the agency’ … = 383) or taxane, trastuzumab (Herceptin), and pertuzumab (THP; n = … 3% considered possibly related to treatment.
ENHERTU® plus pertuzumab …
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FDA Grants Breakthrough Therapy Designation to Frontline T-DXd Plus Pertuzumab in HER2+ Metastatic Breast Cancer
17 Jul 2025 22:29 GMT
… phase 3 DESTINY-Breast09 trial (NCT04784715).
“This … the combination of trastuzumab (Herceptin), pertuzumab, and a … Regarding safety, any-grade treatment-emergent adverse effects ( … www.fda.gov/drugs/;resources-information-approved-drugs/fda-grants- …
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FDA’s Published CRLs Deliver Insight Into the Drug Approval Process
16 Jul 2025 17:44 GMT
… drug developer perform an additional adequate, well-controlled, randomized clinical trial … trastuzumab (Herceptin), for the treatment of patients … Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment …
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PHESGO Implementation Cuts Chair Time and Boosts Efficiency in HER2-Positive Breast Cancer Care
06 Aug 2025 05:02 GMT
… and trastuzumab (Herceptin, PHESGO; Genentech Inc) to reduce treatment burden in patients … each drug separately. It received FDA approval in 2020 for neoadjuvant treatment … , randomized, phase 3 FeDeriCa trial (NCT03493854), which compared PHESGO with …
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Understanding Novel Therapy Utility in HER2+ Breast Cancer Treatment
15 Jul 2025 19:24 GMT
… cancer treatments currently in development.
Hamilton is a board-certified medical oncologist … this includes novel antibody-drug conjugates and novel drugs like Ziihera (zanidatamab … mentally think of it as Herceptin (trastuzumab) and Perjeta (pertuzumab) …