Merck Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

Shots:

• The positive CHMP opinion of Zerbaxa (3gm) is based on P-III ASPECT-NP study assessing Zerbaxa in patients with hospital-acquired pneumonia including ventilator-associated pneumonia. The EC will review CHMP’s opinion to grant centralized marketing authorization to the combination therapy
• The CHMP positive opinion of Keytruda + Inlyta is based on P-III KEYNOTE 426 study which demonstrated improvement in PFS, OS, ORR regardless of PD-L1 expression compared to Sunitinib with its expected EC marketing authorization approval in Q3’19
• Zerbaxa (IV) is antibacterial combination therapy with its supplemental MAA under regulatory review in multiple countries including Canada & Japan. Keytruda is a mAb targeting PD-1 and blocking its interaction with PD-L1 and PD-L2 thereby activating T-lymphocytes affecting both tumor and healthy cells

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