Until this week, the only ADC available in Europe was Seattle Genetics/Takeda’s drug Adcetris. The European Commission’s approval of Kadcyla follows market approval in the US in February, and Switzerland in May for the use of the drug in the treatment of locally advanced or metastatic breast cancer.
Kadcyla is the “only ADC with a dual mode of action, because it combines the mechanisms of action of both trastuzumab (the active ingredient of Herceptin) and a chemotherapy called DM1,” Roche spokesperson Luke Willats told Biopharma-Reporter.com.
“Kadcyla’s mode of action aims to improve efficacy and preserve quality of life as it delivers chemotherapy directly to cancer cells, limiting damage to healthy tissues.”
The drug is made up of Roche’s trastuzumab antibody with ImmunoGen’s cytotoxic agent, joined together by a stable linker using Immunogen’s technology platform.
This latest approval has triggered Roche to pay a $5m milestone to Immunogen who will also be entitled to royalties on any product sales.
Though Roche now has the go ahead to sell Kadcyla, Willats told us “the timing of the commercial availability of Kadcyla will vary among EU member states due to national differences in processes for establishing pricing/reimbursement.”
Last month, the firm announced it was investing CHF190m ($208m) to build a new facility in Basel, Switzerland, to support the manufacture of Kadcyla as well as its future ADC pipeline.
The ADC technology company spoke to this publication earlier this week on the back of a licensing deal with another Swiss Biopharma, Novartis.
There are two ADC technologies with clinical and regulatory validation - the other being Seattle Genetics with Adcetris - spokesperson Carol Hausner sai, and though they have their differences “there is plenty of room for both companies in the ADC space.”