Lung Cancer
This section provides a brief overview of new cancer drugs or new indications
approved by the FDA between May 26 and June 15, 2020. Read More ›
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. Read More ›
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. Read More ›
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. Read More ›
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. Read More ›
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. Read More ›
By Phoebe Starr
Barcelona, Spain—Treatment with ceritinib (Zykadia) led to excellent responses in patients with ALK-positive non–small-cell lung cancer (NSCLC) and brain metastases, according to results of the ASCEND-7 clinical trial, which enrolled only patients with ALK-positive NSCLC with newly diagnosed or progressive brain metastases. Read More ›
On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. The FDA is aiming to provide its decision on the approval of selpercatinib in the third quarter of 2020. Read More ›
By Phoebe Starr
Barcelona, Spain—Osimertinib (Tagrisso), a third-generation EGFR tyrosine kinase inhibitor (TKI), extended overall survival (OS) compared with older TKI EGFR inhibitors, including gefitinib (Iressa) or erlotinib (Tarceva), as first-line treatment for patients with advanced non–small-cell lung cancer (NSCLC) and EGFR mutation in the phase 3 clinical trial called FLAURA. Read More ›
By Phoebe Starr
Barcelona, Spain—The immunotherapy combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) improved overall survival (OS) compared with chemotherapy as first-line treatment in patients with advanced non–small-cell lung cancer (NSCLC) and PD-L1 expression ≥1%, according to results of CheckMate 227. The OS was also improved with nivolumab plus ipilimumab compared with chemotherapy in the total study population and in patients whose tumors had low (<1%) PD-L1 expression. Read More ›