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

Celcuity Preps For Potentially Huge Market After Phase III Gedatolisib Win

 

The biotech announced positive results in the PIK3CA wild-type population in second-line HR+/HER2- breast cancer for its PAM inhibitor.

GSK’s Blenrep US Setback Could Go From Bad To Worse

 

With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

Dispatch Uses ‘Flare’ To Send CAR-Ts To Solid Tumors

 

With $216m in initial funding, the newly launched company is aiming to develop a cell therapy-based universal immuno-oncology option for solid tumor indications.

More from Therapy Areas

GSK’s Blenrep US Setback Could Go From Bad To Worse

 

With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.