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On August 9, 2023, the FDA granted regular approval to pralsetinib (Gavreto; Genentech), a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations, for the treatment of adults with metastatic non–small cell lung cancer and RET fusion–positive gene mutation, as detected by an FDA-approved test. Read More ›

On December 12, 2022, the FDA accelerated the approval of adagrasib (Krazati; Mirati Therapeutics), a RAS GTPase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and KRASG12C mutation (as determined by an FDA-approved test) who have received at least 1 systemic therapy. Adagrasib received breakthrough therapy and orphan drug designations for this indication. Read More ›

On January 26, 2023, the FDA approved pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, as monotherapy for adjuvant treatment of patients with stage IB (T2a ≥4 cm), II, or IIIA non–small-cell lung cancer (NSCLC), after resection and platinum-based chemotherapy. Read More ›

On November 10, 2022, the FDA approved this new immunotherapy, in combination with the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and platinum-based chemotherapy, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and no EGFR or ALK genomic alterations. Read More ›

On November 8, 2022, the FDA approved a new indication for cemiplimab-rwlc (Libtayo; Regeneron), a PD-1 inhibitor, in combination with platinum-based chemotherapy, for the treatment of adults with advanced NSCLC and no EGFR, ALK, or ROS1 aberrations. Read More ›

The phase 3 CheckMate-816 trial establishes a new standard of care for resectable non–small-cell lung cancer (NSCLC): neoadjuvant nivolumab (Opdivo) plus chemotherapy. Read More ›

Patients who take immune checkpoint inhibitors experience a small number of severe side effects, although the majority of them recover with treatment. Read More ›

Sotorasib and adagrasib show promising clinical activity against KRASG12C mutations in patients with NSCLC, giving new hope for patients with the previously regarded “undruggable” disease. Read More ›

A subgroup analysis of the CodeBreaK 100 trial results found that sotorasib achieved a positive response in pretreated patients with KRASG12C mutation–positive NSCLC subtypes. Read More ›

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