The first piece of news to come out of the monthly meeting of the EMA’s human drugs advisory committee – held remotely for the first time – is a green light for Sanofi’s multiple myeloma therapy Sarclisa.
The CHMP positive opinion is for Sarclisa (isatuximab) as a treatment for patients with relapsed and refractory multiple myeloma in combination with Bristol-Myers Squibb’s Pomalyst (pomalidomide) and dexamethasone – a widely-used multiple myeloma regimen known as pom-dex.
The anti-CD38 antibody is an option for patients who have been treated with at least two prior therapies, including BMS’ Revlimid (lenalidomide) and a proteasome inhibitor such as Takeda’s Velcade (bortezomib), and have disease progression.
The positive opinion is based on the ICARIA-MM trial which showed that the addition of Sarclisa increased the response rate to 60% from 35% compared to pom-dex alone, and extended progression-free survival to 11.5 months from 6.5 months.
In the US, the FDA approved the same indication earlier this month and launched at a list price of $5,200 per infusion for a typical patient.
The EMA typically issues a final verdict on CHMP recommendations within a couple of months, but with the coronavirus pandemic disrupting operations there’s no guarantee that will happen on time. Sanofi said in a statement it expects a final decision “in the coming months”.
Sarclisa is the anti-CD38 drug to be approved after Johnson and Johnson’s Darzalex (daratumumab), which is already available across a range of multiple myeloma indications – including first-line use in transplant eligible patients – and has been approved in Europe in 2016.
Darzalex was a $3bn product for J&J last year, so Sanofi has a mountain to climb in its pursuit of the market leader with Sarclisa.
Analysts still think it has blockbuster potential however, because despite a wealth of new myeloma therapies reaching the market in the last few years, multiple myeloma remains incurable – patients invariably relapse and require additional treatment options.
Sanofi says its drug has simpler infusion regimen than Darzalex, which could help uptake, although J&J has been working on a subcutaneous version of its drug which could prove more popular with patients and bolster its franchise.
The company has a range of clinical trials on the go to extend the label for Sarclisa to include earlier lines of therapy and new combinations, as well as studies in other blood cancers and solid tumours.
Sarclisa is one of a clutch of drugs the French drugmaker has developed to try to rebuild its once-mighty oncology franchise after falling behind in the category in recent years, whilst shedding research in other areas like diabetes and cardiovascular disease.
Another is Libtayo (cemiplimab), its latecomer checkpoint inhibitor which has however the first drug in the PD-1/PD-L1 class to be approved for cutaneous squamous cell carcinoma (CSCC), a form of skin cancer.