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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
— June 8, 2020
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
— June 2, 2020
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
— June 2, 2020
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
— May 26, 2020
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
— May 26, 2020
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
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
FDA Approvals, News & Updates
,
Lung Cancer
Web Exclusives
— May 18, 2020
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 Article
FDA Approves Darzalex Faspro as Subcutaneous Formulation for All Patients with Multiple Myeloma
FDA Approvals, News & Updates
Web Exclusives
— May 5, 2020
On May 1, 2020, the FDA approved a new formulation of daratumumab (Darzalex; Janssen Biotech) and hyaluronidase-fihj (Faspro; Janssen Biotech) for the treatment of adults with newly diagnosed or with relapsed or refractory multiple myeloma. This new formulation allows for the subcutaneous administration of daratumumab as an alternative to its intravenous (IV) administration. The new formulation is approved for the indications previously approved for IV daratumumab.
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Comprehensive Cancer Care Centers and Integrated Delivery Systems
COVID-19
Web Exclusives
— May 5, 2020
As a result of the ongoing COVID-19 pandemic, comprehensive cancer care centers have been tasked with significantly altering their strategies for the delivery of care. In this discussion, moderated by Burt Zweigenhaft, PhD, D.Litt, a panel of experts discuss some of the changes that have already been implemented at their centers and future considerations for healthcare systems as they focus on providing safe and effective care on the road to recovery.
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Facing New Challenges in the Delivery of Cancer Care
COVID-19
Web Exclusives
— May 5, 2020
Issues surrounding healthcare insurance continue to unfold in light of the recent COVID-19 pandemic. In this discussion, a panel of managed care experts, moderated by Michael Kolodziej, MD, explore strategies for reducing the total cost of care for patients with cancer and addressing the economic and administrative burdens that practices and payers are facing as a result of the crisis.
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Patient Advocacy During the COVID-19 Crisis
COVID-19
Web Exclusives
— May 5, 2020
Addressing the significant physical and psychosocial needs of patients with cancer during the COVID-19 crisis remains a top priority for healthcare providers. In this discussion, moderated by Elizabeth Franklin, PhD, MSW, a panel of specialists explore efforts underway to advocate for patients who are coping with stress, anxiety, and various economic burdens.
Read Article
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Home
Issues
Online First
Issue Archive
Special Issues
Browse By Topic
Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
COVID-19
Cholangiocarcinoma
View All Topics ›
Conference Correspondent
ESMO 2025 - Wrap-Up: Triple-Negative Breast Cancer
ASCO 2025 - Wrap-Up: Triple-Negative Breast Cancer
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