Roche submits biologics license application for Kadcyla to FDA

Roche completes their supplemental Biologics License Application for Kadcyla

Roche completes their supplemental Biologics License Application for Kadcyla ® a treatment for people with HER2-positive early breast cancer. 

Roche has completed their submission of a supplemental Biologics License Application to the FDA for Kadcyla® (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (eBC) with residual disease after neoadjuvant (before surgery) treatment.

The FDA is reviewing the supplemental biologics license application for Kadcyla 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. For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.

Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues. It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1.

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This supplemental biologics license application for Kadcyla is based on results of the phase III KATHERINE study showing Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50% compared to Herceptin® (trastuzumab) as an adjuvant treatment in people with HER2-positive eBC who have residual disease present following neoadjuvant treatment.

People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease. At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%.

The most common Grade 3-4 side effects (>1%) with Kadcyla in the KATHERINE study were decreased platelet count; high blood pressure; radiation-induced skin injury; numbness, tingling or pain in the hands or feet; decreased neutrophil count; low blood potassium level; fatigue and decrease in red blood cells.

KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive eBC who have pathological invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which in this study is defined as the time from randomisation free from invasive breast cancer recurrence or death from any cause. Secondary endpoints include disease-free survival and overall survival.

Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development said, “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. 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.”