ADC Digest - August 2020
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ADC Digest - August 2020
Kadcyla approved in Japan for adjuvant therapy of HER2-positive early breast cancer
21 Aug 2020
Kadcyla (Trastuzumab emtansine, Tubulin polymerization inhibitor; Chugai (a Roche subsidiary)/Immunogen)
- Approval was based on the results from an open-label, randomized, global Phase 3 KATHERINE study (N=1486); 3-year iDFS rates were 88.3% for KADCYLA vs 77.0% for Herceptin (comparator)
Kadcyla approved for early breast cancer in Japan
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Our outlook:
- Kadcyla is approved in the US (May’19) and EU (Dec’19) for the adjuvant treatment of patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. Now with the approval in Japan will expand its geographic footprint
- It targets patients with residual invasive disease and those that did not achieve pathological response rate (pCR) with neoadjuvant therapy. Kadcyla will be an additional treatment option for these patients in reducing the risk of relapse or progression
– Dr. Kowndinya, CI Scientists
Background:
- Kadcyla is an antibody-drug conjugate. It comprises of the anti-HER2 humanized monoclonal antibody, trastuzumab, and a chemotherapeutic drug, DM1, attached via a stable linker. Kadcyla is designed to target HER2, inhibit HER2 signaling, induce antibody-dependent cell mediated cytotoxicity, and deliver the chemotherapeutic drug DM1 directly inside HER2-positive cancer cells
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