1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Clovis Plans Rucaparib Commercial Launch, After Abandoning Rociletinib

 
• By Emily Hayes

In light of FDA’s plan to issue a complete response letter, Clovis ends development of next-gen EGFR inhibitor rociletinib to save cash and refocuses on approval and launch of PARP inhibitor rucaparib for ovarian cancer.

Clovis Oncology Inc. is gearing up for a commercial launch late this year or in early 2017 of the PARP inhibitor rucaparib in ovarian cancer, after terminating development of the next-generation EGFR inhibitor rociletinib.

Clovis initiated a rolling NDA for rucaparib in April for advanced ovarian cancer with BRCA-mutated tumors, including germline and somatic mutations, an application supported by the Study 010 and ARIEL2...

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
Start Free Trial

Already a subscriber?

More from Clinical Trials

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.

More from R&D

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.