CHMP Recommends Roche ADC for EU Approval of New Indication

November 15, 2019

Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.

On Nov. 15, 2019, Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Kadcyla (trastuzumab emtansine) for the adjuvant (after surgery) treatment of early breast cancer in the European Union (EU).

Kadcyla, an antibody-drug conjugate (ADC), is currently approved as a single agent in more than 100 countries, including the United States and EU, for treating HER2-positive metastatic breast cancer in patients who have previously received Herceptin (trastuzumab) and taxane-based chemotherapy, separately or in combination. With the CHMP’s recommendation, Roche is seeking approval of the drug for adjuvant treatment in adults with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.

A final decision regarding approval of Kadcyla in this setting, along with the full details of the approved indication, is expected from the European Commission in the near future, the company reported.

“In the early breast cancer setting where cure is achievable, it is important to do everything possible to prevent progression to an advanced, incurable stage,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, in a company press release. “This recommendation therefore marks a significant step forward in bringing a potentially transformative treatment option to patients in Europe with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant therapy.”

In the US, Kadcyla is also approved for the adjuvant treatment of people with HER2-positive eBC with residual invasive disease after neoadjuvant treatment that included Herceptin and taxane-based chemotherapy. Roche licenses technology for Kadcyla under an agreement with ImmunoGen.

Source: Roche