Kadcyla will be used to treat the patients who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.
Kadcyla is an antibody-drug conjugate (ADC) designed to provide potent chemotherapy directly to HER2-positive cancer cells and minimise damage to healthy tissues.
It is claimed to be the only ADC approved as a single agent in more than 100 countries to treat people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane-based chemotherapy, separately or in combination.
The European approval was based on data from the phase III KATHERINE study, which demonstrated that Kadcyla significantly minimised the risk of invasive breast cancer recurrence or death from any cause by 50% compared against Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive eBC who have residual invasive disease after neoadjuvant taxane- and Herceptin-based treatment.
KATHERINE is an international, multi-centre, two-arm, randomised, open-label and phase III study designed to assess the efficacy and safety of Kadcyla against Herceptin as an adjuvant therapy in people with HER2-positive eBC who have pathological invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy.
The iDFS is the primary endpoint of the trial. The secondary endpoints comprise of iDFS including second primary non-breast cancer, disease-free survival and overall survival.
In May this year, the Kadcyla was also approved US Food and Drug Administration (FDA) Kadcyla as an adjuvant treatment for HER2-positive early breast cancer in certain patient population. It was approved for the same indication in 27 countries across the globe.
Roche global product development head and chief medical officer Dr Levi Garraway said: “Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible.
“This approval of Kadcyla will allow many more women with HER2-positive early breast cancer to be given a transformative treatment that may cut the risk of their disease returning or progressing.”
In November, Roche agreed to acquire US-based clinical-stage biotechnology company Promedior in a deal valued at around $1.39bn.