Roche has won approval to market oncology drug Kadycla in the EU for use in the treatment of advanced HER2-positive breast cancer.
The approval from the European Commission covers the drug’s use in patients who have previously Roche’s Herceptin (trastuzumab) and taxane chemotherapy, either separately or in combination.
This is in line with the recommendation provided by the European Medicines Agency two months ago, as well as the US Food and Drug Administration (FDA) approval for Kadcyla (trastuzumab emtansine).
The approval opens the drug to a wide new market with one in five of the 700,000 people diagnosed in Europe each year with advanced breast cancer thought to have the HER2 gene mutation.
Expectations are high for the Kadcyla, which is an antibody-drug conjugate (ADC) that combines the monoclonal antibody in Herceptin with ImmunoGen’s DM1, a cytotoxic payload designed to boost its ability to kill tumour cells.
The drug has already achieved respectable success in the US, with Roche reporting sales of 83m Swiss francs ($91m) in the first half of 2013 after its US approval in February.
The EU approval should boost sales further, supporting previously-made predictions from analysts that global annual sales of Kadcyla could reach $3.5bn-$5bn, although this is dependent on its use being expanded to include first-line therapy in breast cancer.
This earlier indication is especially important for Roche considering that one of its major oncology products Herceptin will begin to lose patent protection in 2014, opening it up to cheaper generic competition.
Roche did not say when it expected to launch the drug, although the company’s chief medical officer and head of global product development Dr Hal Barron said plans were in place to make it available to patients.
“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,” he said.