Sanofi’s multiple myeloma drug approved in EU

Sanofi’s new multiple myeloma drug Sarclisa (isatuximab) has been approved in the EU for relapsed/refractory disease, taking on Johnson & Johnson’s well-established blockbuster Darzalex. 

The European Commission has authorised Sarclisa for use in combination with existing standard of care treatment – Bristol-Myers Squibb’s Pomalyst (pomalidomide) in combination with dexamethasone, or pomdex. 

Approval is supported by data from the phase 3 ICARIA-MM trial and a positive opinion from the European Medicines Agency’s CHMP on 26 March. 

European approval also follows approval by the FDA in March as the French pharma stages a comeback in oncology. 

Sanofi used to be a major player in cancer when chemotherapy was standard of care, but has not kept pace with immunotherapy revolution that has taken place over the last decade or so. 

Sarclisa is predicted to be a $1 billion a year drug and like Darzalex it targets the CD-38 receptor that is highly expressed across multiple myeloma cells. 

Although Sanofi is claiming a progression-free survival advantage with Sarclisa, the consensus is that it will not be able to knock Darzalex (daratumumab) off its perch as the standard therapy in multiple myeloma. 

Darzalex is already approved in several multiple myeloma settings and combinations, including relapsed disease and patients who cannot receive an autologous stem cell transplant. 

There are also a host of other multiple myeloma drugs in the pharma pipeline – there are high hopes for drugs such as GSK’s belantamab mafodotin, an antibody-drug conjugate that produced some intriguing early-stage data at the American Society of Clinical Oncology conference earlier this week.

BMS bb2121 CAR-T therapy for multiple myeloma is also at registration stage although it has hit trouble with the FDA, which rejected a filing because technical data was missing from a dossier submitted earlier this year. 

Sanofi is also developing Sarclisa in several other multiple myeloma indications including newly diagnosed patients. 

It also has its own immunotherapy, Libtayo (cemiplimab), which was FDA-approved in advanced cutaneous squamous cell carcinoma in 2018, and is in development in a range of other diseases such as cervical cancer and non-small cell lung cancer. 

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