New breast cancer drug! Kadcyla, a Roche targeted anticancer drug, has applied in Japan for adjuvant treatment of HER2 positive early breast cancer!

September 2, 2019 / BIOON / -- Chugai, a Japanese pharmaceutical company controlled by Roche, a Swiss pharmaceutical giant, recently announced that it had submitted an application to MHLW for approval of kadcyla (trastuzumab emtansine), a targeted drug for HER2, as an adjuvant therapy for HER2 positive early breast cancer Additional indications for patients with (EBC) are: adjuvant (postoperative) treatment for patients with HER2 positive early breast cancer (EBC) who have residual invasive disease after new adjuvant (preoperative) treatment In the United States, the indication of kadcyla was approved by FDA in May this year Previously, FDA awarded kadcyla a breakthrough drug qualification for this indication It is worth mentioning that the indication passed the real-time Oncology Review (RTOR) and assessment aid pilot program review of FDA, and it took only 12 weeks from the submission of the application to the approval Kadcyla is also the first drug approved in Roche pipeline through RTOR pilot project The project aims to explore a more effective review process to ensure that patients can access safe and effective treatment drugs as soon as possible FDA's approval of kadcyla and this Japanese application are based on the data of phase III clinical study Katherine This is an open label, randomized, global study involving nearly 1500 HER2 positive early breast cancer patients with residual disease after new adjuvant therapy (including Herceptin), and evaluating the efficacy and safety of kadcyla and Herceptin in adjuvant therapy The results showed that compared with Herceptin adjuvant therapy, kadcyla adjuvant therapy significantly reduced the risk of recurrence or all-cause death (IDFs) of invasive breast cancer by 50% (HR = 0.50, 95% CI: 0.39-0.64, P < 0.0001) At 3 years of treatment, 83.3% of the patients in kadcyla group had no recurrence of breast cancer, 77.0% in Herceptin group and 11.3% in absolute improvement In addition, the first interim analysis of concurrent secondary endpoints showed that kadcyla did not outperform Herceptin in overall survival In terms of safety, 731 patients (98.8%) in the kadcyla treatment group had adverse events, which was consistent with the safety of kadcyla in HER2 positive metastatic patients Kadcyla is also well tolerated as an adjuvant therapy in HER2 positive early breast cancer patients The most common level 3-4 adverse events (> 1%) of kadcyla were thrombocytopenia, hypertension, radiation-induced skin injury, numbness of hands or feet, tingling or pain, neutropenia, decreased blood potassium level, fatigue and erythrocytopenia Dr Yasushi ITO, executive vice president of Sino foreign pharmaceutical and co director of project and life cycle management department, said: "when the new adjuvant treatment cannot obtain pathological complete response (PCR), there is a high medical demand for the new treatment scheme This application is the first step in providing kadcyla as a new treatment option for patients Our HER2 franchise, consisting of Herceptin ®, perjeta ®, and kadcyla, helps improve the prognosis of HER2 positive breast cancer In this indication, we will continue to discuss with regulatory authorities in order to approve kadcyla as early as possible " The treatment goal of EBC is to provide patients with the best chance of cure, which may involve pre-operative and post-operative treatment as part of a comprehensive treatment Although we are close to this goal every step of the way, many patients still have relapses in the long term The purpose of new adjuvant therapy before surgery is to reduce the tumor and help improve the results of surgery The purpose of adjuvant therapy after surgery is to eliminate any residual cancer cells in the body, so as to help reduce the risk of cancer recurrence Kadcyla is one of the three innovative drugs developed by Roche for HER2 signaling pathway The other two drugs are Herceptin and perjeta The marketing of these three drugs has changed the clinical treatment mode of HER2 positive breast cancer HER2 positive breast cancer is a particularly aggressive breast cancer, affecting about 15-20% of breast cancer patients For early breast cancer (EBC), the purpose of new adjuvant (preoperative) treatment is to reduce the tumor volume so that it can be more easily removed by surgery The purpose of adjuvant (postoperative) treatment is to eliminate any residual cancer cells to reduce the risk of cancer recurrence Kadcyla is a HER2 targeted therapy, which was approved to market in 2013 Up to now, it has been approved by 104 countries in the world It is the first and only antibody drug conjugate (ADC) approved as a single preparation for the treatment of HER2 positive transitional breast cancer patients who have received Herceptin and paclitaxel chemotherapy (alone or in combination) The drug is composed of trastuzumab and immunogen's cytotoxic DM1, which is delivered to HER2 positive breast cancer cells through a stable linker Kadcyla has two anticancer properties: the HER2 inhibition of trastuzumab and the cytotoxicity of DM1 Original source: Chugai files for additional indication for anti-HER2 anti drug reconcile kadcyla for adjust therapy of HER2 positive early break cancer