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Yervoy/Nivolumab May Need Stronger Survival Data To Be First Choice In Melanoma

 
• By Emily Hayes

Bristol’s combo demonstrates similar response rate as PD-1 alone, but with much better survival rates in a small melanoma study presented at ASCO. Due to toxicities, including one death, some say combination would need to shore up survival benefit to become first choice in frontline therapy.

CHICAGO – The combination of Bristol-Myers Squibb Co.’s CTLA-4 inhibitor Yervoy (ipilimumab) and PD-1 inhibitor nivolumab will need to show very high survival rates in large studies to secure a role in frontline treatment of melanoma, in light of the significant toxicities for the combo and the strong performance of PD-1 monotherapy, said specialists at the American Society of Clinical Oncology annual meeting.

In follow-up data for the combo in 53 Stage 3/4 melanoma patients taking part in a broader Phase I trial,...

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• By Vibha Sharma

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• By Eliza Slawther

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

 
• By Eliza Slawther

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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.

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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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order.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.