Roche's antibody-drug conjugate Kadcyla looks well positioned for approval for adjuvant treatment of breast cancer, following the release of positive top-line findings from the KATHERINE study on Oct. 15.
Kadcyla (ado-trastuzumab emtansine) includes Roche's HER-2 antibody Herceptin (trastuzumab) and the chemotherapy DM1 joined together with a stable linker. The drug is part of Roche's broad strategy for building out its breast cancer franchise past the maturing Herceptin
Although no biosimilar versions of Herceptin have launched in the US yet, Mylan NV and Biocon Ltd. received FDA approval for their Ogivri (trastuzumab-dkst) in December 2017 and have a settlement with Roche to launch at an undisclosed date. (Also see "Biosimilar Litigation Trends: Settlements, Declaratory Judgment Rejections, Congressional Intervention" - Pink Sheet, 12 August, 2018.) Amgen Inc./Allergan PLC, Teva Pharmaceutical Industries Ltd./Celltrion Inc. and Pfizer Inc. have received complete response letters for Herceptin biosimilars, and Merck & Co.Inc./Samsung Bioepis Co. Ltd. have a filing pending with the FDA. Also see "Pending Biosimilars" - Pink Sheet, 13 February, 2017
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