NICE recommends against Darzalex to treat MM

The U.K.'s NICE issued draft guidance recommending against the use of Darzalex daratumumab monotherapy to treat relapsed and refractory multiple myeloma following treatment with a proteasome inhibitor and an immunomodulatory agent. The committee said it could not identify the most plausible incremental cost-effectiveness ratio (ICER) for Darzalex because the cost-effectiveness evidence was "unreliable." The evidence Johnson & Johnson submitted came from the single-arm Phase III SIRIUS (MMY2002) and Phase I/II GEN501 trials. NICE noted that "few" patients in the trials received the licensed dose of Darzalex, and that data on overall survival (OS) were immature, with over 40% of patients alive at the end of the trials...