Roche’s Kadcyla approved in the EU for advanced HER2-positive breast cancer

Roche announced that Kadcyla (trastuzumab emtansine or T-DM1), the latest targeted medicine from its HER2 franchise and its first antibody-drug conjugate, has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer.

Specifically, Kadcyla is indicated as a single agent for the treatment of adults with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin (trastuzumab) and a taxane, separately or in combination. The indication also stipulates that those treated should either have received prior therapy for locally advanced or metastatic disease, or have had disease recurrence during or within six months of completing adjuvant therapy.

“Kadcyla’s approval in the EU is important because this type of targeted medicine has been shown in clinical studies to offer clear benefits for people with advanced HER2-positive breast cancer,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Now that Kadcyla has been approved, we can begin discussions with the relevant EU reimbursement authorities to ensure that people who need this medicine can receive it as quickly as possible. »

The decision is based on results from the pivotal Phase III EMILIA study in which people previously treated with Herceptin and a taxane for their HER2-positive advanced breast cancer were randomised to receive either Kadcyla or a standard treatment, lapatinib and Xeloda (capecitabine). People receiving Kadcyla survived significantly longer than those who received lapatanib and Xeloda (30.9 vs 25.1 months) and also lived for nearly 10 months (9.6 months) without their disease getting worse, a median of 3.2 months longer than those who received lapatinib and Xeloda. They also experienced fewer of the severe side effects commonly associated with chemotherapy, as Kadcyla’s targeted mode of action works to deliver the treatment directly to cancer cells, limiting damage to healthy tissues.


Source: Roche


CHMP recommends EU approval of Roche’s Subcutaneous Herceptin for HER2 positive breast cancer

  • New injectable administration takes two to five minutes, rather than 30 to 90 minutes with the current intravenous form, potentially saving both healthcare resources and patients’ time
  • Herceptin® is a personalised medicine used to treat more than 80,000 HER2-positive breast cancer patients in Europe each year

Roche (SIX: RO, ROG; OTCQX: RHHBY) is pleased to announce that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has today recommended EU approval of a subcutaneous formulation of Herceptin® (trastuzumab) for the treatment of patients with HER2-positive breast cancer. Since Herceptin’s first approval in 1998 this targeted medicine has been used to treat more than 1.3 million patients worldwide.

At present, Herceptin is given to patients intravenously, which takes 30 to 90 minutes per dose. By contrast, the new subcutaneous formulation of Herceptin can be administered in two to five minutes by a simple injection under the skin.1

« Over the last 14 years, Herceptin has revolutionised the treatment of HER2-positive breast cancer. Today, more than 80,000 patients in Europe receive Herceptin each year,” said Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “EU approval of this subcutaneous form of Herceptin would provide a more convenient option for patients that potentially saves time and healthcare resources. »

The CHMP’s positive opinion was based on data from the pivotal phase III HannaH study which showed the efficacy and safety of the subcutaneous formulation of Herceptin were comparable to treatment with Herceptin administered intravenously.1

The subcutaneous formulation of Herceptin uses technology developed by Halozyme Therapeutics, Inc. that reversibly breaks down hyaluronan, a gel-like substance that forms a barrier between cells under the skin. This enables the relatively large volume of the subcutaneous formulation of Herceptin to be rapidly dispersed over a greater area.

Roche is working with regulatory authorities around the world to ensure patients who are eligible for treatment with Herceptin have the option of choosing this more convenient therapy.


Source: Roche