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Lung Cancer

Rearrangement during transfection (RET) fusions can result in gain- or loss-of-function mutations and unchecked cellular proliferation. Although RET fusions are present in only a small percentage of cases of non–small-cell lung cancer, evidence shows they may be meaningful drug targets.
There are several oncogenic driver mutations that are actionable for treatment in cases of NSCLC. Evidence has shown that molecularly targeted approaches can result in positive outcomes for patients with NSCLC, underscoring the importance of research into biomarker testing and molecular profiling.
Four retrospective studies on treatment with immune checkpoint inhibitors in patients with NSCLC have shown only limited clinical benefit in patients with RET-rearranged lung cancer.
Ongoing trials of two recently approved RET inhibitors, pralsetinib and selpercatinib, are producing encouraging safety and efficacy data in patients with RET fusion–positive NSCLC.
Although researchers have made great advances in NSCLC screening, diagnosis, and treatment, there remain several areas of unmet need, including the development of individual risk-based screening criteria, research into optimal biopsy types for molecular profiling, and greater focus on effective side-effect management plans for patients on multimedication regimens.
On June 15, 2020, the FDA accelerated the approval of lurbinectedin (Zepzelca; Jazz Pharma/Pharma Mar), an intravenous alkylating drug, for the treatment of adults with metastatic small-cell lung cancer that has progressed during or after platinum-based chemotherapy. The FDA granted lurbinectedin an orphan drug designation for this indication.
On May 29, 2020, the FDA approved ramucirumab (Cyramza; Eli Lilly) in combination with erlotinib (Tarceva) for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Ramucirumab was previously approved for several types of cancer, including, in combination with docetaxel, for metastatic NSCLC, after platinum-based chemotherapy.
On May 26, 2020, the FDA approved nivolumab (Opdivo; BMS) and ipilimumab (Yervoy; BMS) plus chemotherapy as first-line treatment of recurrent or metastatic squamous or nonsquamous non–small-cell lung cancer (NSCLC), regardless of PD-L1 expression, and with no EGFR or ALK aberrations. On May 15, the FDA approved nivolumab plus ipilimumab as first-line treatment of metastatic NSCLC with PD-L1 ≥1% expression.
On May 18, 2020, the FDA approved a new indication for atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for the first-line treatment of adults with metastatic non–small-cell lung cancer (NSCLC) whose tumor has high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area), and no EGFR or ALK genomic aberrations, as determined by an FDA-approved test.
On May 15, 2020, the FDA approved a new indication for the first immunotherapy combination with the PD-1 inhibitor nivolumab (Opdivo; BMS) and the CTLA-4 inhibitor ipilimumab (Yervoy; BMS) as first-line treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and PD-L1 expression of ≥1%, as determined by an FDA-approved test, but without EGFR or ALK genomic alterations.
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