Roche has submitted a supplemental biologics license application in the US seeking to expand the use of Kadcyla (trastuzumab emtansine) to include the adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.
The US Food and Drug Administration (FDA) is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programmes, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.
Kadcyla was also granted Breakthrough Therapy Designation (BTD), which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.
The application is based on results of the international, multi-centre, two-arm, randomised, open-label phase III KATHERINE study showing Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin (trastuzumab).
"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" said Sandra Horning, MD, Roche's chief medical officer and head of Global Product Development.
"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.”
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues.