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Sign Of The Times: Late-Stage Cancer Vaccines On Display At ASCO

 
• By Shirley Haley

Vindicated by the approvals of Provenge and Yervoy, a host of therapeutic cancer vaccines is working through late-stage trials with the regulatory finish line in sight, and some of those companies will be presenting data at the American Society of Clinical Oncology meeting in Chicago June 1-5.

The regulatory finish line is in sight for a growing number of cancer vaccines that represent diverse mechanisms, manufacturing platforms and components, all designed to harness the patient’s own immune system to fight cancer with a high degree of efficacy and few side effects. A number of those companies will be presenting clinical data on their projects at the coming American Society of Clinical Oncology meeting in Chicago June 1-5.

Along with news on the firm’s second-generation projects, four abstracts will be presented further elucidating the character of Dendreon Corp.’s breakthrough prostate cancer therapy Provenge (sipuleucel-T), the first approved...

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.