Nå sitter vi jo faktisk på fasiten i hva som kreves da, i og med at Copanlisib fikk accelerated Approval:
104 pasienter. Dette er bortimot på flekken det samme tallet NANO kommer til å falle ned på når PARADIGME er ferdig,
Bayer Receives FDA Approval for Aliqopa™ (copanlisib) 60 mg vial for Injection in Adults with Relapsed Follicular Lymphoma after Two Prior Systemic Therapies
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Accelerated approval based on overall response rate (ORR) of 104 adult patients with relapsed follicular lymphoma (FL) from the Phase II CHRONOS-1 study(1)
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Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(1)
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Aliqopa achieved a 59% ORR in patients with relapsed FL n=104 (95% CI 49, 68)




