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GSK’s Phase II, Single-Arm Trial For Jemperli In Rectal Cancer Gets Panel Nod

 
• By Sue Sutter

Oncologic Drugs Advisory Committee members generally agreed with GSK that a randomized study in dMMR/MSI-H patients would not be feasible; despite the favorable vote, panelists still raised concerns about use of 12-month clinical complete response as the primary endpoint.

Plane taking off
GSK's plan for accelerated approval based on single-arm studies was cleared for takeoff by ODAC. • Source: Shutterstock

GSK plc’s proposal for use of single-arm trials to support accelerated approval of Jemperli (dostarlimab-gxly) in locally advanced rectal cancer gained backing from a majority of a US Food and Drug Administration advisory committee members on 9 February, despite reservations about the proposed primary endpoint.

Eight of the 13 members of the Oncologic Drugs Advisory Committee said a proposed single-arm, multicenter, Phase II study, in addition to an ongoing single-arm study at Memorial Sloan Kettering Cancer Center, would be sufficient to characterize the PD-1 inhibitor’s benefits and risks in

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More from US FDA Performance Tracker

Keep Talking: US FDA’s Beleagured Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers

Global Pharma Guidance Tracker - March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.