FDA Approves Isatuximab-irfc for Treatment of Relapsed Refractory Multiple Myeloma

Isatuximab-irfc (Sarclisa; Sanofi), in combination with pomalidomide and dexamethasone (pom-dex), was approved this week by the FDA for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least 2 prior therapies.

The approval comes amid data from the ICARIA-MM clinical trial, the only randomized phase 3 trial to evaluate an anti-CD38 drug in combination with pom-dex that has presented results to date.

Currently, MM is the second most common blood cancer, affecting more than 130,000 US patients. A key catalyst in MM, CD38, is highly and uniformly expressed on MM cells and cell surface receptors, indicating the potential efficacy of anti-CD38 therapeutics, such as isatuximab-irf, in treating MM.

In the clinical trial findings, isatuximab-irf in combination with pom-dex was linked with a significant reduction in the risk of disease progression or death in patients with RRMM by 40% compared with pom-dex alone. Additionally, the combination therapy compared with pom-dex alone demonstrated statistically significant improvement in median progression free survival (11.53 months vs 6.47 months) and overall response rate (60.4% vs 35.3%; P <.0001).

Principal investigator of ICARIA-MM, Paul Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, stressed the difficulty of treating RRMM, which is associated with poor prognosis. “Most patients with multiple myeloma unfortunately relapse and become refractory to currently available therapies,” said Richardson. “Sarclisa [isatuximab-irf] used in combination with pomalidomide and dexamethasone offers an important new treatment option for patients in the United States living with this incurable disease.”

Isatuximab-irf will be offered intravenously and is dosed at 10 mg/kg, in combination with pom-dex, every week for 4 weeks and then biweekly until disease progression or unacceptable toxicity. The US list price for isatuximab-irf is $650 per 100 mg vial and $3250 per 500 mg vial, translating to a cost of $5200 per infusion for a typical US patient (154-176 lbs).

Paul Hudson, chief executive officer of Sanofi, noted that the company will continue to evaluate isatuximab-irf in a comprehensive clinical program in MM, other blood cancers, and solid tumors. “At Sanofi, we are focused on discovering and developing medicines that may change the practice of medicine, and Sarclisa [isatuximab-irf] offers a potential new standard of care in the United States,” said Hudson.