Pfizer’s Lorbrena (lorlatinib) Receives FDA’s Approval for Expanding its Indication to Treat ALK-Positive Metastatic Lung Cancer

March 4, 2021 Auto Bot approval, Expand, FDA, Pfizer, receives, regulatory, Treatment 0

Shots:

  • The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated advanced ALK-positive NSCLC
  • The P-III study resulted in a 72% reduction in risk of progression or death as assessed by BICR. The prespecified exploratory analysis showed IC-ORR was (82% vs 23%) as assessed by BICR; IC-DOR was 12 mos. or longer in (79% vs 0%) patients
  • Lorbrena is a third-generation TKI and got accelerated approval in 2018. The FDA has now converted accelerated approval to full approval

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Geelong Medical and Health Group

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