FDA reviews Sanofi's multiple myeloma drug isatuximab

The FDA has begun its review of Sanofi’s multiple myeloma drug isatuximab, as the French pharma prepares for a tussle with Johnson & Johnson’s blockbuster Darzalex.

However, the French pharma must wait for the standard 10-month review period as in this case the drug is not likely to be a significant improvement over standard care in relapsed/refractory multiple myeloma (RRMM).

Sanofi said the FDA has set a target action date for a decision of April 30, 2020 for the investigational monoclonal antibody.

Like Darzalex, isatuximab targets the CD38 receptor of a plasma cell, and Sanofi is hoping to steal market share from J&J’s drug, which generated $629 million in the first quarter alone.

The FDA is reviewing results from ICARIA-MM, an open-label pivotal phase 3 clinical trial of isatuximab in patients with RRMM.

Sanofi has opted to combine isatuximab with Celgene’s Revlimid (pomalidomide) and results of the trial proved to be a talking point at the American Society of Clinical Oncology (ASCO) conference.

Results showed a 40% reduction in the risk of disease progression or death - but it remains to be seen whether doctors will decide isatuximab instead of Darzalex (daratumumab) on a regular basis.

At the conference Kantar Health’s Kelly Clapp said that a range of factors could influence doctors’ prescription choices if isatuximab is approved, including comorbidities and infusion times.

However with the FDA setting a longer review period, the perception could be that isatuximab is a “me too” drug, with price being a potential factor influencing doctors’ decisions as well.

Sanofi is also testing isatuximab in combination with other standard treatments for people with relapsed/refractory or newly diagnosed multiple myeloma.

It is also being investigated as a treatment for other blood cancers and solid tumours.

It has received orphan designation from both the FDA and European Medicines Agency, and in the second quarter of 2019 the EMA began its review, paving the way for potential launches late next year or early in 2021.