SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug major Roche (RHHBY) announced Monday the approval of Kadcyla (trastuzumab emtansine) by the US Food and Drug Administration.
The approval is for adjuvant, or after surgery, treatment of people with HER2-positive early breast cancer or eBC who have residual invasive disease after neoadjuvant, or before surgery, taxane and Herceptin (trastuzumab)-based treatment.
The approval is based on results of the phase III KATHERINE study, evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive eBC.
The study showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin as an adjuvant treatment in people with HER2-positive eBC who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment.
The FDA rapidly reviewed and approved the application under the FDA's Real-Time Oncology Review or RTOR and Assessment Aid pilot programmes, which ensure safe and effective treatments are available to patients as early as possible.
The company noted that Kadcyla is the first Roche medicine approved under the RTOR pilot programme.
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