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Previously, Kadcyla approved the treatment of non-excisible or relapsed HER2-positive breast cancer patients.
this latest approval, Kadcyla will provide a new treatment to improve prognosis for HER2-positive early breast cancer patients who receive new assisted (preoperative) treatment without pathological complete remission (pCR).
this approval, based on data from the Open Label, Random, Global Phase III KATHERINE study.
the study was conducted in 1,486 herl2-positive early breast cancer patients who received new complementary treatments, including Herceptin, without pathological complete remission (pCR), and assessed the efficacy and safety of Kadcyla for complementary (postoperative) treatment.
results showed that Kadcyla-assisted therapy showed superiority over Hersertine-assisted therapy in terms of iDFS survival (iDFS), significantly reducing the risk of recurrence or total cause of death of insanity breast cancer by 50% (HR-0.50, 95% CI:0.39-0.64, p<00001).
three years of treatment, 83.3 percent of patients in the Kadcyla treatment group did not have a recurrence of breast cancer, compared with 77.0 percent in the Hersheytine treatment group, an absolute improvement of 11.3 percent.
the study, Kadcyla's safety was consistent with previously observed in the previously approved HER2-positive metastasis breast cancer treatment, and Kadcyla was also well-to-do as an auxiliary treatment for HER2-positive early breast cancer.
early stage breast cancer (eBC) treatment aims to provide patients with the best chance of treatment as part of a comprehensive treatment that may involve pre- and post-those treatments.
that while we approach this goal every step of the way, many patients still have relapses in the long term.
-assisted treatment before surgery is designed to reduce tumors and help improve surgical outcomes, and post-surgery complementary treatment is designed to eliminate any remaining cancer cells in the body to help reduce the risk of cancer recurrence.
Kadcyla is one of three innovative drugs developed by Roche for the HER2 signaling path, the other two being Hessetin and Perjeta.
the launch of these three drugs has changed the clinical treatment model for HER2-positive breast cancer.
HER2-positive breast cancer is a particularly aggressive form of breast cancer that affects about 15-20% of breast cancer patients.
for early breast cancer (eBC), the purpose of the new complementary (preoperative) treatment is to reduce tumor volume so that it is easier to surgically remove, and the purpose of the assisted treatment is to eliminate any remaining cancer cells to reduce the risk of cancer recurrence.
Kadcyla is a HER2 targeted therapy approved in 2013 and has been approved by more than 100 countries worldwide to date, making it the first and only antibody drug coupled (ADC) approved as a single agent for the treatment of HER2-positive metastasis breast cancer patients who have previously received chemotherapy (individually or jointly) for Hercetin and yew.
the drug is made up of trastuzumab, the active drug ingredient of Hercetin, and ImmunoGen's cytotoxic agent DM1, which is delivered to HER2-positive breast cancer cells via a stable link.
Kadcyla has two anti-cancer properties: HER2 inhibition of curvature monoantigen and cytotoxicity of DM1.
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