Celgene’s Revlimid Approved For Third-Line Use In Mantle Cell Lymphoma

Lenalidomide becomes first oral therapy approved in this disease but soon could be joined by ibrutinib, Pharmacyclics/J&J’s investigational agent that has received FDA “breakthrough therapy” designation.

Celgene Corp.’s Revlimid (lenalidomide) has added a new indication for relapsed/refractory mantle cell lymphoma but might soon face competition in this setting from Pharmacyclics Inc./Johnson & Johnson’s “breakthrough therapy” ibrutinib.

On June 5, FDA approved Celgene’s supplemental NDA for treatment of patients with mantle cell lymphoma (MCL) whose disease has...

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 United States

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

More from North America