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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
FDA Approvals, News & 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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Retevmo First Therapy Approved for 3 Types of Cancers with RET Mutations
FDA Approvals, News & Updates
June 2020, Vol 11, No 3
On May 8, 2020, the FDA accelerated the approval of a new kinase inhibitor, selpercatinib (Retevmo; Loxo Oncology) capsules, for the treatment of 3 types of cancer—metastatic non–small-cell lung cancer (NSCLC), metastatic medullary thyroid cancer, and other types of thyroid cancer—that are associated with
RET
gene mutations or fusions, as determined by an FDA-approved test. Selpercatinib is the first therapy approved specifically for the treatment of patients with cancer that is linked to
RET
mutations or fusions. The FDA granted selpercatinib breakthrough therapy and orphan drug designations.
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Tabrecta First FDA-Approved Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping
FDA Approvals, News & Updates
June 2020, Vol 11, No 3
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 the treatment of metastatic NSCLC associated with mutations that lead to mesenchymal-epithelial transition (MET) exon 14 skipping, as determined by an FDA-approved test. The FDA granted capmatinib breakthrough therapy and orphan drug designations.
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Pemazyre First FDA-Approved Therapy for Cholangiocarcinoma plus FGFR2 Fusion
FDA Approvals, News & Updates
June 2020, Vol 11, No 3
On April 17, 2020, the FDA approved pemigatinib (Pemazyre; Incyte), an oral kinase inhibitor, as the first treatment for adults (aged ≥18 years) with previously treated, locally advanced or metastatic cholangiocarcinoma that is associated with a fibroblast growth factor receptor 2 (
FGFR2
) gene fusion or other rearrangements, as detected by an FDA-approved test. This is the first targeted therapy approved for patients with advanced cholangiocarcinoma. Until now, the standard of therapy for this patient population has been chemotherapy combinations.
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Jelmyto First FDA-Approved Therapy for Low-Grade Upper-Tract Urothelial Cancer
FDA Approvals, News & Updates
June 2020, Vol 11, No 3
On April 15, 2020, the FDA approved mitomycin gel (Jelmyto; UroGen Pharma), an alkylating drug as the first treatment for patients with low-grade upper-tract urothelial cancer. Mitomycin is a combination of chemotherapy and a sterile hydrogel that stops the transcription of DNA into RNA and halts the synthesis of protein, thereby blocking the ability of cancer cells to multiply. The FDA granted mitomycin gel priority review, breakthrough therapy, fast track, and orphan drug designations.
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FDA Approves Cyramza plus Tarceva for First-Line Treatment of Metastatic NSCLC with EGFR Mutation
FDA Approvals, News & 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.
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Opdivo plus Yervoy and Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
FDA Approvals, News & 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.
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Tecentriq plus Avastin First Immunotherapy Regimen Approved for Metastatic Hepatocellular Carcinoma
FDA Approvals, News & 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.
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Lynparza Approved for Metastatic Prostate Cancer with HRR Mutation
FDA Approvals, News & 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.
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Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
FDA Approvals, News & 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 Article
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