FDA accepts BLA filing for Sanofi's rival to J&J's Darzalex

The FDA has accepted Sanofis filing for approval of its Darzalex rival in relapsed/refractory multiple myeloma. Sanofi will learn whether the FDA will approve anti-CD38 antibody isatuximab by the end of April 2020. Isatuximab impressed at the American Society of Clinical Oncology's (ASCO's) annual meeting last month with phase 3 data linking its addition to pomalidomide and dexamethasone to a 40% reduction in the risk of disease progression. The data established isatuximab as a legitimate rival to Johnson & Johnson’s Darzalex, particularly as Sanofi’s drug has a shorter infusion time and lower rate of infusion-related reactions. Sanofi could gain the chance to challenge J&J in the U.S. next year. The FDA recently accepted a filing for approval of the drug, setting a PDUFA date of April 30. The FDA action comes shortly after its European counterpart accepted a filing for approval in its jurisdiction. Winning approval would set Sanofi up to eat away at J&J’s blockbuster franchise and turn isatuximab, which it developed with ImmunoGen, into the poster child for its efforts to rely more heavily on its own R&D teams. Analysts at Jefferies expect global sales of isatuximab to peak at $1 billion. Darzalex sales fell short of analyst expectations at points during 2018, but the drug has nonetheless made a fast start. Sales topped $2 billion last year and, boosted by first-quarter sales of $629 million, are on track to grow again in 2019. Those figures show the opportunity available to isatuximab is far bigger than its sales forecast suggests, but some analysts doubt it will take a big slice of the market.