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First-Line Breast Cancer Approval Opens The Door For Pfizer’s Palbociclib

 
• By Emily Hayes

The CDK 4/6 inhibitor Ibrance (palbocliclib) just got its first approval in first-line metastatic breast cancer and Pfizer is losing no time on development, with trials of other indications planned or ongoing, including different tumor types.

FDA’s accelerated approval of Pfizer Inc.’s CDK4/6 inhibitor Ibrance (palbociclib) in previously untreated metastatic breast cancer hits the first goal in a broad development program that crosses lines of therapy and encompasses different tumor types.

FDA granted accelerated approval for the drug Feb. 3, more than two months ahead of its April 13 user fee date, as an add-on to the standard hormonal therapy letrozole...

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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.