More Competition In Prostate Cancer? Medivation’s Enzalutamide Now With FDA

Medivation and Astellas have submitted their castration-resistant prostate cancer drug enzalutamide to FDA and hope to gain priority review for the long-anticipated therapy.

Medivation Inc. and Astellas Pharma Inc.are counting on the strength of the Phase III trial results for their andogren receptor signaling inhibitor enzalutamide to gain priority review from FDA for their newly submitted NDA, despite the presence of other breakthrough prostate cancer therapies like Zytiga (abiraterone) and Jevtana (cabazitaxel) on the market.

Enzalutamide, formerly known as MDV3100, has generated a lot of buzz since the Phase III trial was stopped early because of positive results in castration-resistant prostate cancer patients, and analysts...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

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

 

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 

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 

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

More from R&D

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By 

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

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 

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.