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Daiichi Sankyo

Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study Evaluating Enhertu in HER2+ Metastatic Gastric Cancer Patients

Shots: The data from P-III (DESTINY-Gastric04) study showed statistically significant and clinically meaningful improvement in OS vs ramucirumab & paclitaxel in 2L HER2+ (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma pts. The safety profile observed in DESTINY-Gastric04 aligns with Enhertu's established safety record. The company expects to present data…

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Daiichi Sankyo & Astrazeneca

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots: The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…

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VIEWPOINTS_Nirja Patel_2023

Nirja Patel, Senior International Product Manager at Roche Shares her Views on the US FDA Approval of the PATHWAY anti-HER2 Test

Shots:  Nirja gave the details of the PATHWAY anti-HER2 (4B5) to identify metastatic breast cancer patients with low HER2 expression through its scoring algorithm that helps pathologists to identify “low expressors” of HER2  She told PharmaShots about how this test is able to identify patients who may benefit from Enhertu as a treatment option. She…

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Viewpoints_Garret Hampton

Garret Hampton, President, Clinical Sequencing & Oncology at Thermo Fisher Scientific Shares Insights from the Approval of the First NGS-Based Companion Diagnostic for HER2-Mutant NSCLC

Shots: Garret spoke about the approval of the first NGS-based companion diagnostic to aid in selecting NSCLC patients with HER2  activating mutations for treatment with ENHERTU Garret also talked about the Oncomine Dx Target Test and its availability for different targeted therapies in multiple geographies The interview highlights how Thermo Fisher is working to develop accessible CDx solutions…

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