The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems
Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
Recommendation is based on pivotal data from the phase III POLARIX study
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