EMA predicts 'no ADC influx' following Roche's Kadcyla launch

Last week, Roche launched its breast cancer therapy Kadcyla in the UK following its approval by the European Medicines Agency (EMA) last November​, making it only the second ADC to be available in the region after Seattle Genetics/Takeda’s Adcetris.

Biopharma interest in ADCs has been around for a while but investment in technologies and capabilities has skyrocketed in the past few months with companies including AstraZeneca​, Eli Lilly​, Novartis​ and Roche​ itself pumping money into developing the small and large molecule hybrids, which have been described as everything from “groundbreaking”​ to “sexy.”​​

However, whilst the specific targeting nature of the compounds has not escaped industry’s attention the EMA told Biopharma-Reporter.com it does not believe there will be an influx of applications for new products.

“We have not seen many ADCs reaching the marketing authorisation application stage and we do not expect to see a high number of applications for this type of medicines in the future,”​ said spokesperson Sophie Labbé.

She also added the regulatory approval pathway of such drugs was not a factor holding back ADC makers and no specific guidelines were being prepared.

“There is nothing unique about ADCs that is not covered by regulatory considerations for small molecules and biologicals combined,”​ she said, “with the exception of the compound stability issue which is also covered by existing guidance.”​

Labbé would not comment specifically on Kadcyla but for ADCs generally the scientific requirements from the regulatory view are somewhat enhanced by the complex nature of the drug.

“Both the metabolism of the cytotoxic (this is generally waived for biologicals) and the immunogenicity from the biological (this is rarely an issue with small chemical molecules) have to be considered,”​ with additional data on the stability of the conjugate being required.

Kadcyla & Roche​

The antibody and cytotoxic of Kadcyla itself is made at a number of sites, Roche spokesperson Claudia Schmitt told this publication, with the drug being conjugated at its own site in Switzerland.

In light of the UK launch we asked her how much the drug would cost, and though Schmitt told us local market conditions dictated the price, in the US the monthly cost for a patient is $9,800 (€7,100).

As for the firm’s commitment to ADCs, “currently Roche has eight ADCs in clinical development,”​ we were told.

“We have collaborations in place with multiple partners including ImmunoGen, Seattle Genetics, Nerviano Medical Sciences and Spirogen to explore the potential of ADCs,”​ she added, citing that using a number of approaches and technologies gives the firm the best opportunity to develop these products.