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Daratumumab has direct and indirect anti-cancer activity by binding to CD38, inducing direct apoptosis of tumor cells and triggering complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) [64]

If treatment is recommended, a clinician evaluation and valid prescription are required

For example, if the manufacturer of a Part B rebatable biosimilar biological product is granted a severe supply chain disruption rebate reduction request for its product due to a natural disaster that occurred in January 2025 and then experiences a second severe supply chain disruption caused by a second, distinct natural disaster in July 2025, CMS will not grant the second rebate reduction request

Follow-up Repeat metabolic markers after 8-12 weeks if the protocol is being continued or adjusted