Shots:

• The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer- consistent with the approved dosing in ES-SCLC
• The company anticipates the PDUFA date in Q4’20. The sBLA is based on multiple clinical trials- including results of P-III CASPIAN trial in ES-SCLC which used the 4wks.- FD regimen during maintenance
• If approved- the new dosing will be available as an alternative to the approved weight-based dosing of 10mg/kg q2w

 Ref: AstraZeneca | Image: Fierce Pharma

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