1. Pink Sheet
  2. >>Product Reviews

US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer

 
• By Sue Sutter

Richard Pazdur tells the Pink Sheet that program for concurrent submission of oncology applications and collaborative review by global regulators also could speed approval in smaller countries; first applications under Project Orbis were for use of Lenvima/Keytruda combination for endometrial cancer in US, Canada, and Australia.

FDA's Project Orbis
Project Orbis provides a framework for concurrent submission and review of oncology drugs by FDA and foreign regulators. • Source: US FDA

The US Food and Drug Administration has started conducting collaborative reviews with foreign regulators under a new initiative that could help streamline global clinical trials while also speeding the approval of supplemental indications for cancer drugs in smaller countries.

On 17 September, the FDA’s Oncology Center of Excellence (OCE) announced the launch of Project Orbis, a collaboration that provides a framework for concurrent submission and review of

Lenvima/Keytruda Combo Indication In US

Treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior

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 Product Reviews

More from Pink Sheet

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 
• By Francesca Bruce

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.