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Opdivo Approved to Treat Metastatic Small Cell Lung Cancer

Data showed that 12% responded to treatment based on assessment by a Blinded Independent Central Review, regardless of PD-L1 expression; 11% had a partial response, and 1 patient had a complete response (0.9%).
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First Biosimilar For Cancer Treatment Approved

The approval was based on evidence from animal study data, human pharmacokinetic and pharmacodynamics data, and clinical immunogenicity data which demonstrated Mvasi is a biosimilar to Avastin.
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Rituxan Gains Expanded Approval in Peds

Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are rare diseases that are generally specific to the lungs, kidneys and upper airways.