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

19 Apr 2024

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...