Roche has moved a step closer to EU approval for Kadcyla, its follow-up to breast cancer blockbuster Herceptin, after a positive verdict from the Committee for Medicinal Products for Human Use (CHMP).
The CHMP also gave its blessing to Bayer and Algeta’s Xofigo (radium Ra 223 dichloride) for castration-resistant prostate cancer (CRPC ).
In the case of Kadcyla (trastuzumab emtansine), the CHMP recommended its approval for HER2-positive metastatic breast cancer patients who have previously been treated with Herceptin (trastuzumab) and taxane-based chemotherapy.
Kadycla is an antibody-drug conjugate (ADC) that combines the monoclonal antibody in Herceptin with ImmunoGen’s DM1, a cytotoxic payload designed to boost its tumour cell-killing power.
The product was approved in the US in February, making sales of 83m Swiss francs ($91m) in the first half of 2013 thanks to what Roche described as “encouraging uptake”, and has also just been approved in Japan where it will be sold by Chugai.
The new treatment is seen as a critical new product for Roche’s HER2-targetting franchise, given that Herceptin – which generated first-half sales of $3.3bn – could face biosimilar competition from 2016. At its peak Kadcyla could achieve sales of $2bn to $5bn depending on follow-up indications, according to analysts.
ImmunoGen is also celebrating the good news, as CHMP backing and Japanese approval are worth $5m apiece in milestone payments for the company.
Meanwhile, Xofigo was backed by the CHMP as a treatment for adults CRPC who also have symptomatic bone metastases and no known visceral metastases. The drug was approved for the same indication in the US in May after a fast-track review, and, like Kadcyla, has been tipped as a potential blockbuster with sales of more than $1bn at peak.
Algeta said last month Xofigo had got off to a good start in the US, with sales of $600,000 in its first four weeks on the market.
There is still a pressing need for new therapies for CRPC, which historically has been associated with a median survival of less than two years.