FDA to Review Kadcyla for Certain HER2-positive Early-stage Breast Cancer Patients

FDA to Review Kadcyla for Certain HER2-positive Early-stage Breast Cancer Patients
The U.S. Food and Drug Administration is reviewing Kadcyla (trastuzumab emtansine) as a post-surgery treatment for early-stage breast cancer patients whose tumors produce the HER2 factor, Roche announced. The supplemental biologics license application — which is for patients who had residual disease after their pre-surgery treatment — is being reviewed under the FDA's real-time oncology review and assessment aid pilot programs, meant to explore a more efficient review process, so patients can more quickly gain access to treatments found safe and effective. For the same indication, Kadcyla was also granted breakthrough therapy designation, intended to accelerate the development and review of medicines that may treat serious or life-threatening diseases. "Kadcyla was granted Breakthrough Therapy Designation and is also the first Roche medicine to be reviewed under the FDA's Real-Time Oncology Review pilot programme; both FDA initiatives aim to expedite reviews and bring medicines to patients sooner," Sandra Horning, MD, Roche's chief medical officer and head of global product development, said in a
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