Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval

 
• By Joseph Haas

The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.

FDA food and drug administration approval health pharmacy certification
Roche gets a third indication for NSCLC drug Alecensa

Roche Holding AG got US Food and Drug Administration approval for expansion of lung cancer therapy Alecensa’s label to include adjuvant treatment of early-stage, anaplastic lymphoma kinase (ALK)-positive patients, making it the first drug to gain approval in that setting, but the revenue potential for the added indication appears to be fairly minimal.

Key Takeaways

  • Roche gets US supplemental approval for Alecensa to treat adjuvant ALK-positive NSCLC, expanding a label that already includes first- and second-line therapy.

Initially given accelerated approval in 2015 for second-line ALK-positive non-small cell lung cancer (NSCLC), Alecensa (alectinib) obtained full approval and...

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