Momentum In Prostate Cancer Therapy Moves Up To First-Line CRPC

The most recent events in the fast-evolving castration-resistant prostate cancer field illustrate how the major advances in therapy for patients who failed chemotherapy are now spreading to the larger population of CRPC patients receiving first-line therapy for metastatic disease. The upcoming year should see Phase III results from candidates ranging from a kinase inhibitor to an antisense agent.

Now that the treatment landscape has thoroughly transformed for post-chemotherapy metastatic castration-resistant prostate cancer, the fast-evolving space is starting to see shifts in standard care in earlier stages of the disease, beginning with the approval of Johnson & Johnson’s Zytiga for the pre-chemotherapy setting and rapidly progressing with a lineup of clinical trials set to report data in the coming year.

Localized prostate cancer is initially managed through surgical and/or chemical castration with hormonal (androgen deprivation) therapy. Should it advance beyond that, castration- or hormone-resistant prostate cancer has been treated with...

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.