Roche's HER2-Targeted ADC Kadcyla Approved by European Commission for Adjuvant Treatment of HER2-Positive Early Breast Cancer with Residual Invasive Disease
Dec 20, 2019 08:29
CST Updated
08:29
Roche
Oncology Drug Research, Development, and Manufacturing
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
December 20, 2019 /BioValleyBIOON/--Swiss pharmaceutical giant Roche recently announced that the European Commission (EC) has approved the HER2-targeted drug Kadcyla (trastuzumab emtansine) for patients with HER2-positive early-stage breast cancer who have residual invasive disease in the breast and/or lymph nodes following neoadjuvant (preoperative) treatment based on taxanes and HER2-targeted therapy.Breast Cancer(eBC) patients' adjuvant (postoperative) treatment.
In the United States, Kadcyla received accelerated approval from the FDA this May for adjuvant (postoperative) treatment of patients with HER2-positive early breast cancer (eBC) who have residual invasive disease after receiving neoadjuvant (preoperative) therapy. Previously, the FDA had granted Kadcyla Breakthrough Therapy Designation for this indication. Notably, this indication was approved throughFDAreal-timeTumorFollowing review under the Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, the approval process took only 12 weeks from application submission to approval. Kadcyla was also the first drug in Roche’s pipeline to be approved through the RTOR pilot program. This initiative aims to explore a more efficient review process to ensure patients gain timely access to safe and effective therapies.
This EU approval is based on data from the Phase III KATHERINE clinical trial. The study demonstrated that, among patients with HER2-positive early breast cancer who had residual disease after neoadjuvant therapy, adjuvant treatment with Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival, iDFS) by 50% compared with adjuvant Herceptin (HR=0.50, 95% CI: 0.39–0.64, p<0.0001). At three years post-treatment, 83.3% of patients in the Kadcyla group were free from breast cancer recurrence, compared with 77.0% in the Herceptin group, representing an absolute improvement of 11.3%. In this study, the safety profile of Kadcyla was consistent with previous findings. The most common grade 3–4 adverse events (>1%) in the Kadcyla group were thrombocytopenia,Hypertension, radiation-induced skin injury, numbness, tingling, or pain in the hands or feet, neutropenia, decreased potassium levels, fatigue, and decreased red blood cells.
Dr. Levi Garraway, Chief Medical Officer and Global Head of Product Development at Roche, stated: “Early-stage breast cancer is curable, and in this setting, it is crucial to do everything possible to prevent disease progression to an incurable advanced stage. The approval of Kadcyla will provide a transformative treatment option for patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant therapy in Europe, helping to reduce the risk of disease recurrence or progression.”
The treatment goal for early breast cancer (eBC) is to provide patients with the best chance of cure, which may involve preoperative and postoperative therapies as part of a comprehensive treatment approach. Although each step brings us closer to this goal, many patients still experience disease recurrence in the long term. Neoadjuvant therapy administered before surgery aims to shrinkTumorand help improve surgical outcomes. The purpose of administering adjuvant therapy after surgery is to eliminate any residual cancer cells in the body, thereby helping to reduce the risk of cancer recurrence.
Kadcyla is one of the three innovative drugs developed by Roche targeting the HER2 signaling pathway, the other two being Herceptin and Perjeta. The launch of these three drugs has transformed the clinical treatment paradigm for HER2-positive breast cancer. HER2-positive breast cancer is a particularly aggressive form of breast cancer, affecting approximately 15–20% of breast cancer patients. For early-stage breast cancer (eBC), the goal of neoadjuvant (preoperative) therapy is to reduceTumorIts size facilitates easier surgical removal, and the purpose of adjuvant (postoperative) therapy is to eradicate any residual cancer cells to reduce the risk of cancer recurrence.
Kadcyla is a HER2-targeted therapy that was approved for marketing in 2013. To date, it has been approved in more than 100 countries worldwide and is the first and only antibody-drug conjugate (ADC) approved as a single agent for the treatment of patients with HER2-positive metastatic breast cancer who have previously received trastuzumab and taxane chemotherapy (either separately or in combination). The drug consists of trastuzumab (the active pharmaceutical ingredient in Herceptin) linked to ImmunoGen’s cytotoxic agent DM1 via a stable linker, thereby delivering DM1 to HER2-positive breast cancer cells. Kadcyla possesses two anticancer properties: the HER2-inhibitory effect of trastuzumab and the cytotoxicity of DM1. (Bioon.com)