Novartis’ skin cancer therapy Odomzo has been approved by the European Commission, a month after the drug was cleared in the US.
Odomzo (sonidegib) is used to treat locally-advanced basal cell carcinoma – the most common form of skin cancer – in patients for whom surgery or radiation therapy has either been unsuccessful or is inappropriate.
While BCC is not as deadly as other skin cancer types such as melanoma, it can be highly disfiguring and invasive, particularly if it reaches an advanced stage, according to Novartis. It accounts for 80% of all non-melanoma cases and while only 1% to 10% of patients develop advanced disease they have few treatment options.
The number of cases of BCC is also rising by around 10% a year thanks to the increasing age of the population and exposure to ultraviolet light.
In the phase II BOLT trial, a once-daily 200mg dose of sonidegib achieved a clinically-significant response – with total disappearance of the tumour in some cases. Median progression-free survival has not been reached but is now put at 22 months by central reviewers of the data and 19 months by clinical investigators.
Novartis has a number of melanoma therapies thanks to its recent asset swap deal with GlaxoSmithKline, so Odomzo complements that portfolio and will be marketed through the same channels.
The drug is an inhibitor of a drug target known as smoothened (SMO), part of the Hedgehog pathway that is implicated in the pathology of a number of different tumour types.
It will compete in the marketplace against Roche’s Erivedge (vismodegib), another SMO inhibitor that has been on the market since 2012 and achieved sales of 72m Swiss francs ($75m) in the first six months of the year, a 27% increase year-on-year.
Neither drug is expected to be a big seller thanks to the small patient population with advanced BCC, with Erivedge’s growth rate already slowing down, although peak sales could be boosted by new indications.
According to clinicaltrials.gov, sonidegib is currently being assesses in combination with Millennium Pharma’s Velcade (bortezomib) and Celgene’s Revlimid (lenalidomide) in multiple myeloma, with paclitaxel for recurrent ovarian cancer and alongside Novartis’ PI3K inhibitor buparlisib in BCC.
Other studies of the drug are ongoing in prostate cancer, pancreatic adenocarcinoma, ovarian cancer, non-small cell lung cancer and triple-negative breast cancer, as well as haematological malignancies such as acute leukaemia.