Non-Small Cell Lung Cancer (NSCLC)

Under the FDA’s Real-Time Oncology Review Pilot Program and Project ORBIS, the FDA is reviewing a supplemental new drug application for lorlatinib (Lorbrena) as a first-line treatment for patients with ALK-positive metastatic non–small cell lung cancer.

Full approval has been granted by the FDA to osimertinib (Tagrisso) for use as adjuvant therapy following tumor resection among patients with non–small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.

Janssen submitted a biologics license application to the FDA seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Though researchers found that Black patients with early-stage non-small cell lung cancer are now more likely to receive the most effective treatment compared to a decade ago, the disparity for this patient population persists.

Adagrasib demonstrated an acceptable safety profile and promising clinical activity in pretreated patients with non-small cell lung cancer, colorectal cancer, and other solid tumors with a KRAS G12C mutation.

An interim analysis of the trial revealed that among patients with previously untreated advanced ALK-positive non-small cell lung cancer, those who received lorlatinib (Lorbrena) had significantly longer PFS, a higher overall and intracranial response, and better quality of life.

These study results suggest that osimertinib as adjuvant therapy is an effective treatment strategy for patients with stage IB to IIIA EGFR-positive non-small cell lung cancer following complete tumor resection.

The FDA approved a 1500 mg fixed dose of durvalumab (Imfinzi) administered every 4 weeks for the treatment of unresectable stage III non-small cell lung cancer after chemoradiation therapy and previously treated advanced bladder cancer.