FDA Approval of Frontline Brigatinib in ALK+ mNSCLC


An expert in the treatment of lung cancer discusses the use of brigatinib in this patient case and in general use for ALK+ metastatic NSCLC.

Karen Reckamp, MD: Moving specifically to this patient’s treatment with brigatinib, there was a recent FDA approval in 2020 for brigatinib for the frontline setting. This had previously been approved for patients post-crizotinib, and then because of the ALTA-1L trial, where brigatinib was compared to crizotinib, there was an approval for the frontline setting. This is important for patients with ALK-positive non–small cell lung cancer, as more choices improve the chances of patients having long-term benefits and being able to choose the best drug based on toxicity and efficacy in the frontline setting. For this patient, utilizing brigatinib is well tolerated, and the importance of taking the 90-mg dose for the first week, evaluating pulmonary symptoms and other toxicity, then moving up to the 180 mg if tolerated, again, is important for this patient.

Transcript edited for clarity.

Case: A 68-Year-Old Woman with ALK+ Non–Small Cell Lung Cancer

Initial presentation

  • A 68-year-old woman presented with fatigue, wheezing and decreased appetite
  • PMH: unremarkable
  • PE: wheezing on auscultation; ECOS PS 1

Clinical Workup

  • Labs: WNL 
  • Chest x-ray showed a left lower lobe mass
  • Chest/abdomen/pelvic CT scan confirmed a 6.8-cm left lower lobe lung mass and a suspicious liver lesion
  • PET scan showed activity in the left lower lobe mass and liver
  • MRI of the brain showed several subcentimeter lesions without edema
  • Bronchoscopy with transbronchial biopsy of the left lower lobe mass confirmed lung adenocarcinoma
  • Molecular testing: NGS revealed EML4/ALK fusion+, EGFR-, ROS1-, BRAF-, KRAS-, NTRK-, MET-, RET-, PD-L1 0% by IHC
  • Staging: IVB adenocarcinoma


  • Patient was started on brigatinib 90 mg qDay for 7 days; well tolerated; dose was increased to 180 mg qDay

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