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Kadcyla was developed by Genentech in 2008, an American biotechnology company which is a subsidiary of Roche, a Swiss multinational pharmaceutical company, that acquired Genentech in 2009. The antibody trastuzumab was developed by Genentech in the early 1990s and subsequently marketed as the cancer drug Herceptin.
The development of linker molecules and cytotoxic payloads conjugated to the trastuzumab antibody led to the production of a targeted ADC which became known as Kadcyla (Lewis Phillips et al., 2008). This trastuzumab ADC demonstrated improved adjuvant treatment of HER2+ breast cancer when compared to treatment with trastuzumab alone when tested in clinical trials (Diéras et al., 2017)
Immunogen Inc. developed the drug payload, known as DM1 or mertansine in the early 1990s (Chari et al., 1992). Immunogen Inc. is currently a subsidiary of AbbVie who licensed their maytansinoid technology to Genentech in 2000 (Rx Communications Group, 2005).
Kadcyla bulk drug substance is manufactured by Lonza, a contract manufacturing organisation, in Visp, Switzerland.
DSM, Inc. Greenville, North Carolina, USA manufactures the drug product. At their USA site the bulk drug substance is sterile filtered, formulated, filled and lyophilised.
The drug is marketed by Genentech in the US and Roche in the EU.
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