TOKYO - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has obtained approval for anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla Intravenous Infusion 100 mg and 160 mg [generic name: trastuzumab emtansine (genetical recombination)] from the Ministry of Health, Labour and Welfare for an additional indication of HER2-positive postoperative breast cancer.

'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. Osamu Okuda, Chugai's President and COO. 'As a leading company in the field of oncology, Chugai will strive to promote the appropriate use of this treatment for the benefit of patients.'

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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