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FDA Updates

This section provides a brief overview of new cancer drugs approved by the FDA between November 25, 2020, and December 18, 2020.
On September 4, 2020, the FDA accelerated the approval of pralsetinib (Gavreto; Blueprint Medicines/Genentech), an oral RET inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and RET-activating fusions, as detected by an FDA-approved test.
This section provides a brief overview of new cancer drugs approved by the FDA between July 31, 2020, and September 4, 2020.
This section provides a brief overview of new cancer drugs or new indications approved by the FDA between June 30, 2020, and July 24, 2020.
This section provides a brief overview of new cancer drugs or new indications approved by the FDA between May 26 and June 15, 2020.
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 June 10, 2020, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous-cell carcinoma after fluoropyrimidine-based and platinum-based chemotherapy. Nivolumab has been previously approved for many indications, but this is its first indication for esophageal cancer.
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 29, 2020, the FDA approved the immunotherapy atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, in combination with bevacizumab (Avastin; Genentech), a vascular endothelial growth factor inhibitor, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received systemic therapy. This is the first immunotherapy regimen approved by the FDA for this type of HCC.
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