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FDA Updates
Gavreto, RET Inhibitor, FDA Approved for Metastatic NSCLC with RET Fusions
FDA Updates
Web Exclusives
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.
Read More ›
Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
FDA Updates
,
Lung Cancer
Web Exclusives
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.
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Opdivo Approved for Advanced Esophageal Squamous-Cell Carcinoma
FDA Updates
Web Exclusives
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.
Read More ›
FDA Approves Cyramza plus Tarceva for First-Line Treatment of Metastatic NSCLC with EGFR Mutation
FDA Updates
,
Lung Cancer
Web Exclusives
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 ›
Opdivo plus Yervoy and Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
FDA Updates
,
Lung Cancer
Web Exclusives
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 ›
Tecentriq plus Avastin First Immunotherapy Regimen Approved for Metastatic Hepatocellular Carcinoma
FDA Updates
,
Hepatocellular Carcinoma
Web Exclusives
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.
Read More ›
Lynparza First Targeted Therapy Approved for Metastatic Prostate Cancer with HRR Mutation
FDA Updates
,
Prostate Cancer
Web Exclusives
On May 19, 2020, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca), a PARP inhibitor, for the treatment of men with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic
HRR
mutation, as determined by an FDA-approved test, whose disease progressed after enzalutamide (Xtandi) or abiraterone acetate (Zytiga) therapy. Olaparib is the first FDA-approved PARP inhibitor for prostate cancer.
Read More ›
Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
FDA Updates
,
Lung Cancer
Web Exclusives
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 ›
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
FDA Updates
,
Lung Cancer
Web Exclusives
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 ›
Tabrecta First FDA-Approved Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping
FDA Updates
Web Exclusives
On May 6, 2020, the FDA accelerated the approval of oral capmatinib (Tabrecta; Novartis), a kinase inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC). Capmatinib is the first agent approved by the FDA for metastatic NSCLC with mutations that lead to MET exon 14 skipping, as determined by the FoundationOne CDx assay, which is approved as a companion diagnostic for capmatinib.
Read More ›
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February 2024 - Vol 17 No 1
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ESMO 2023 - Small Cell Lung Cancer
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