Swiss drugmaker F. Hoffmann-La Roche has announced that the EU’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending authorization of Kadcyla as a single agent for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Kadcyla is an HER2-targeted therapy that connects the HER2 inhibition of trastuzumab (the active ingredient found in Herceptin) and DM1, the cytotoxic chemotherapy, using a stable linker.
The CHMP's positive opinion for Kadcyla (trastuzumab emtansine or T-DM1) is based on results from the Phase III EMILIA study, which found that Kadcyla helped HER2-positive breast cancer patients to live for 9.6 months without their disease getting worse and extended their life expectancy to 30.9 months, and showed a tolerable safety profile with fewer severe side effects.
The Phase III EMILIA study involved comparing Kadcyla alone to lapatinib in combination with Xeloda in 991 patients with HER2-positive locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Roche chief medical officer and global product development head Dr Hal Barron said Kadcyla's highly effective, targeted mode of action offers patients a chance to extend their lives with fewer of the side effects commonly experienced with chemotherapy.
"We hope that this new medicine is soon available to patients with metastatic breast cancer in Europe," Dr Barron added.
The European Commission is anticipated to issue a final decision by the end of 2013.
