FDA to rule on Sanofi’s myeloma drug by April of next year

The French drugmaker said the agency had accepted its application for isatuximab, a potential competitor to J&J’s Darzalex. Positive Phase III data for isatuximab were presented at the ASCO meeting last month.

The Food and Drug Administration will review an application from a French pharmaceutical company for a drug to treat multiple myeloma that will compete with an agent already on the market for several years.

Paris-based Sanofi said Wednesday that the FDA had accepted its application for isatuximab and intends to decide on whether to approve it by April 30, 2020. The drug is a monoclonal antibody that targets CD38, the same target as Johnson & Johnson subsidiary Janssen’s Darzalex (daratumumab), a CD38-targeting monoclonal antibody that originally won approval in 2015.

Sanofi’s filing is based on results of the Phase III ICARIA-MM study, which compared isatuximab combined with Celgene’s Pomalyst (pomalidomide) and dexamethasone against Pomalyst and dexamethasone alone. Data from ICARIA-MM were presented last month at the American Society of Clinical Oncology’s annual meeting.

ICARIA-MM enrolled 300 patients who had received at least two prior lines of therapy, which had to include at least two consecutive cycles of another Celgene drug, Revlimid (lenalidomide), plus a proteasome inhibitor like Amgen’s Kyprolis (carfilzomib) or the Takeda Pharmaceutical Co. drugs Velcade (bortezomib) or Ninlaro (ixazomib).

Isatuximab nevertheless faces stiff competition if it wins FDA approval. Darzalex is already approved for combination with Pomalyst and dexamethasone in third-line treatment, in addition to several other indications. However, that indication is based on Phase I data, and not the much more robust Phase III randomized data that ICARIA-MM provides for isatuximab. A randomized Phase III study for Darzalex, Pomalyst and dexamethasone is underway in Europe, sponsored by the European Myeloma Network and supported by Janssen.

Most recently, on June 27, Darzalex won FDA approval for combination with Revlimid and dexamethasone in first-line patients ineligible for autologous stem cell transplant.

At ASCO last month, Dana-Farber Cancer Institute myeloma program director and isatuximab data presenter Dr. Paul Richardson said in an interview that isatuximab is not associated with complement activation. That means it can be more readily administered than Darzalex to patients with asthma and chronic obstructive pulmonary disease, which Richardson called “not a trivial population.”

Isatuximab could also potentially have a role to play among patients for whom Darzalex has failed, given that the epitope of CD38 that it binds to is distinct from that of the Janssen drug.

Moreover, the same oral session at ASCO where the isatuximab data were presented included data on a subcutaneous formulation of Darzalex that, compared to the currently approved intravenous version, is just as efficacious, has fewer toxicities and is much faster to administer. Isatuximab is also administered intravenous infusion.

Photo: Alaric DeArment, MedCity News