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Perjeta Panel Review Could Pave Way For Neoadjuvant Approvals

 
• By Emily Hayes

The September advisory committee review of Roche’s sBLA for Perjeta will be the first test of the agency’s guidance on using accelerated approval for neoadjuvant breast cancer.

FDA’s upcoming advisory committee review of Roche/Genentech Inc.’s Perjeta for a new indication in neoadjuvant breast cancer will help lead the way for approvals of drugs in early treatment, a new paradigm for oncology drug development.

The Oncologic Drugs Advisory Committee will meet Sept. 12 to consider a supplemental BLA for Perjeta (pertuzumab) in patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer (tumor size...

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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

 
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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.