Lurbinectedin for Small-Cell Lung Cancer: Luis Paz-Ares, MD

Last month, the FDA granted accelerated approval to lurbinectedin (ZepzelcaTM, Pharma Mar, S.A.) for adults with metastatic small-cell lung cancer experiencing disease progression on or after platinum-based chemotherapy. In this interview, Luis Paz-Ares, MD, principal investigator of the phase 2 basket trial PM1183-B-005-14 (Study B-005; NCT02454972), on which the approval was based, spoke with i3 Health about the approval's significance, notable adverse events with lurbinectedin, and the wealth...
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Lurbinectedin Approved: Metastatic Small-Cell Lung Cancer

The FDA has granted accelerated approval to lurbinectedin (ZepzelcaTM, Pharma Mar, S.A.) for adults with metastatic small-cell lung cancer (SCLC) experiencing disease progression on or after platinum-based chemotherapy. The efficacy of lurbinectedin, a selective inhibitor of oncogenic transcription, was investigated in a multinational, single-arm, open-label phase 2 basket trial, PM1183-B-005-14 (Study B-005; NCT02454972), which enrolled adults with SCLC previously treated with only one chemothe...
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Ramucirumab/Erlotinib Approved: Metastatic Non-Small Cell Lung Cancer

The FDA has approved ramucirumab (Cyramza®, Eli Lilly and Company) in combination with erlotinib for patients with previously untreated advanced non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 substitution mutation. The approval was based on RELAY (NCT02411448), a phase 3 trial that enrolled 449 patients with untreated stage IV NSCLC. Eligible patients were at least 18 years old, had an Eastern Cooperative Oncology Group (ECOG) perfo...
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Atezolizumab for PD-L1–High Non-Small Cell Lung Cancer: David Spigel, MD

Atezolizumab (Tecentriq®, Genentech, Inc.) was recently approved by the FDA for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with high expression of programmed death ligand-1 (PD-L1). The approval was based on IMpower110, a phase 3 trial led by David Spigel, MD, Chief Scientific Officer and Director of the Lung Cancer Research Program at Sarah Cannon Research Institute in Nashville, Tennessee. In this interview with i3 Health, Dr. Spigel discusses the s...
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FDA Approves Nivolumab/Ipilimumab/Platinum-Doublet Chemotherapy: NSCLC

Nivolumab (Opdivo®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb) in combination with 2 cycles of platinum-doublet chemotherapy has been FDA approved for treatment-naive patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Approval was based on the randomized, open-label trial CHECKMATE-9LA (NCT03215706). A total of 719 patients with met...
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