publication date: May. 10, 2019
Drugs & Targets
FDA approves Kadcyla for breast cancer
FDA has approved Genentech’s Kadcyla (ado-trastuzumab emtansine) for adjuvant treatment of people with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and Herceptin (trastuzumab)-based treatment.
“This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot program, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated,” Sandra Horning, chief medical officer and head of Global Product Development, said in a statement. “With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure.”
The FDA rapidly reviewed and approved the application under the FDA’s Real-Time Oncology Review and Assessment Aid pilot programs, 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 (invasive disease-free survival) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin as an adjuvant treatment in people with HER2-positive EBC who have residual invasive … Continue reading FDA approves Kadcyla for breast cancer
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