Genentech’s Kadcyla approved by FDA in early breast cancer treatment

Genentech, a member of Roche, announced that the FDA has approved Kadcyla for adjuvant, or after surgery, treatment of people with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment. The FDA reviewed and approved the application, leading to an approval 12 weeks after completing the submission. Kadcyla is the first Genentech medicine approved under the RTOR pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. This approval is based on results of the Phase III KATHERINE study showing 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. At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%.

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