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Roche's Alecensa® (alectinib) Receives CFDA Priority Review for 1L ALK +ve mNSCLC

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Roche's Alecensa® (alectinib) Receives CFDA Priority Review for 1L ALK +ve mNSCLC

Shots:

  • Alecensa approval in china is after 8 & 9 mos post EMA and US FDA approvals- Alecensa is now approved in over 57 countries
  • The approval is based on the pivotal Ph III studies ALEX and ALESIA assessing Alecensa vs crizotinib- and two Ph II assessing Alecensa in patients on or are intolerant to crizotinib
  • ALEX results: mPFS (27.7mos vs 7.4mos); ORR (82.9% vs 75.5%); Death reduced to 53%

Ref: Roche | Image:  Roche


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