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 press release. "We are working closely with the FDA to bring Kadcyla to people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy as early as possible," she added. Kadcyla, marketed by Genentech, is an antibody-drug conjugate that uses the trastuzumab antibody (the active ingredient in Herceptin) to deliver a cytotoxic agent to cancer cells. Kadcyla delivers the cytotoxic agent directly into HER2-positive cancer cells, in this way limiting damage to healthy tissues. The FDA’s decision was based on results from the Phase 3 KATHERINE trial (NCT01772472), where Kadcyla cut in half the risk of invasive disease or
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