'It is said that the prognosis is poor when pathologic complete response (pCR) is not obtained by neoadjuvant therapy in the treatment of HER-2 positive early breast cancer. In the KATHERINE study, which was evaluated for regulatory approval, Kadcyla reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin. We are very pleased that this approval addresses an unmet medical need for patients seeking a cure, and contributes to the advancement of treatment,' said Dr.
This approval is based on the results from an open-label, randomized, global phase III KATHERINE study. The study evaluated the efficacy and safety of Kadcyla adjuvant therapy in 1,486 patients with HER2-positive early breast cancer who did not have pathologic complete response following neoadjuvant therapy including Herceptin. The results confirmed the superiority of Kadcyla over Herceptin in terms of the primary endpoint of invasive disease-free survival (unstratified hazard ratio: 0.50 [95% confidence interval: 0.39-0.64, log-rank test, p
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