SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (ROG.SW, RO.SW), announced completing the submission of a supplemental Biologics License Application to the U.S. FDA for Kadcyla for after surgery treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment. The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programs. For the indication, Kadcyla was also granted Breakthrough Therapy Designation.
Kadcyla is an antibody-drug conjugate engineered to deliver potent chemotherapy directly to HER2-positive cells. It is designed to limit damage to healthy tissues, although it can still affect them.
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