FDA approves Roche's Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment

F. Hoffmann-La Roche Ltd / FDA approves Roche's Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• The approval is based on data showing Kadcyla cut the risk of disease recurring by half compared to Herceptin in the adjuvant setting for specific patients with HER2-positive early breast cancer

The application was approved in just over 12 weeks under the US FDA's Real-Time Oncology Review pilot programme

Basel, 06 May 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Kadcyla (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (eBC) who have residual invasive disease after neoadjuvant (before surgery) 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 programme, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "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 goal in treating eBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach.^1,2 While we come closer to this goal with each advance, many people still have a disease recurrence in the long-term.³ Neoadjuvant treatment is given before surgery with the goal of shrinking tumours and helping to improve surgical outcomes.² Adjuvant treatment is given after surgery and aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.²