Kadcyla on course for European approval following CHMP opinion

Roche has secured a positive opinion from the EU's Committee for Medicinal Products for Human Use ( CHMP) for its oncology candidate Kadcyla, an antibody-drug conjugate which is a follow-up to the breast cancer blockbuster Herceptin.

Roche has secured a positive opinion from the EU's Committee for Medicinal Products for Human Use ( CHMP) for its oncology candidate Kadcyla, an antibody-drug conjugate which is a follow-up to the breast cancer blockbuster Herceptin.

The CHMP recommended approval of Kadcyla (trastuzumab emtansine or T-DM1) as a single agent for the treatment of adult patients...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Anticancer

More from Therapy Areas

Lilly’s Kisunla Label Update Lowers ARIA-E Risk For Alzheimer’s Patients

 
• By 

The updated US FDA label modifies dose titration based on TRAILBLAZER-ALZ 6, a study that showed a more gradual rise in dosing levels reduced ARIA-E incidence without reducing amyloid clearance.

Actithera Raises $75m To Enter Competitive FAP-Targeting Radioligand Field

 

While companies such as Eli Lilly and Roche have faced setbacks to their fibroblast activation protein-targeting oncology therapies, Actithera believes its radiopharmaceuticals platform will prove more successful.

J&J Seeks Schizophrenia Relapse Indication For Caplyta

 

The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.