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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,...

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Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

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Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.