European regulator clears Roche's Kadcyla for advanced breast cancer

Roche announced Wednesday that the European Commission approved Kadcyla (trastuzumab emtansine) for use in patients with previously treated HER2-positive advanced breast cancer. Hal Barron, the company's chief medical officer, remarked that following clearance of the antibody-drug conjugate, Roche "can begin discussions with the relevant EU reimbursement authorities to ensure that people who need this medicine can receive it as quickly as possible."

Specifically, Kadcyla has been approved 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 drugmaker added that the indication specifies that patients treated with Kadcyla 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.

In September, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Kadcyla, also known as T-DM1. "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," commented Barron. In the Phase III EMILIA study, patients given Kadcyla had median survival of 30.9 months, versus 25.1 months for those who received treatment combining Roche's Xeloda (capecitabine) and GlaxoSmithKline's Tykerb (lapatinib). In addition, those who took Kadcyla had median progression-free survival of 9.6 months, compared to 6.4 months for those given Xeloda plus Tykerb.

Kadcyla, which uses technology licensed from ImmunoGen, was cleared in September in Japan for use in HER2-positive inoperable or recurrent breast cancer and was approved in Canada for patients with HER2-positive metastatic breast cancer. The drug was also authorised by the FDA in February for patients with HER2-positive metastatic breast cancer. For related analysis, see ViewPoints: Analyst expectations surge for Roche's breast cancer treatment Kadcyla.

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