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Buoyed By T-DM1 EMILIA Data, Roche Leaps To Early Breast Cancer Trial

 
• By Emily Hayes

In Phase III EMILIA study, Herceptin-containing antibody drug conjugate demonstrates three-month progression-free survival benefit, trend toward overall survival and, importantly, better safety profile. Results pave way for new trials in earlier disease using new FDA approval pathway.

CHICAGO–Roche/Genentech Inc. is riding the momentum created with the release of the EMILIA trial of its Herceptin-based antibody conjugate T-DM1 in late-stage breast cancer and preparing to conduct a study in early-stage breast cancer using a new accelerated approval pathway created by FDA, as part of the company’s “three-pronged” development strategy in breast cancer, Roche execs said during an analyst briefing at the annual American Society of Clinical Oncology meeting June 3.

A follow-on to the blockbuster Herceptin (trastuzumab), T-DM1 (trastuzumab emtansine) combines trastuzumab with a highly potent, cytotoxic agent called DM1,...

More from Clinical Trials

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By Vibha Sharma

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

More from R&D

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By Vibha Sharma

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges