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Web Exclusives
Gilotrif Receives New Indication as First-Line Treatment for Metastatic NSCLC with Nonresistant EGFR Mutations
FDA Approvals, News & Updates
Web Exclusives
— July 9, 2018
On January 12, 2018, afatinib (Gilotrif; Boehringer Ingelheim) received FDA approval as first-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) associated with nonresistant
EGFR
mutations as identified via an FDA-approved test. Afatinib received orphan drug status for this indication, and was approved under the FDA priority review process.
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Lutathera First Radioactive Drug Approved for Adults with Gastroenteropancreatic Neuroendocrine Tumors
FDA Approvals, News & Updates
Web Exclusives
— July 9, 2018
On January 26, 2018, the FDA approved lutetium Lu 177 dotatate (Lutathera; Advanced Accelerator Applications), a radioactive drug, for the treatment of adults with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutetium Lu 177 dotatate was approved under the FDA’s priority review process, and was designated as an orphan drug.
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Zytiga Receives New Indication, with Prednisone, for Metastatic, High-Risk Castration-Sensitive Prostate Cancer
FDA Approvals, News & Updates
Web Exclusives
— July 9, 2018
On February 7, 2018, abiraterone acetate (Zytiga; Janssen Biotech) received FDA approval for use, in combination with prednisone, for the treatment of patients with metastatic, high-risk castration-sensitive prostate cancer (CSPC). The FDA approved this new indication under its priority review program.
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Imfinzi First Treatment Approved to Reduce Disease Progression in Unresectable Stage III NSCLC After Chemoradiation
FDA Approvals, News & Updates
Web Exclusives
— July 9, 2018
On February 16, 2018, the FDA approved an expanded indication for durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for the treatment of patients with unresectable stage III non–small-cell lung cancer (NSCLC) that did not progress after chemoradiation. Durvalumab received accelerated approval in 2017 for the treatment of certain patients with metastatic or locally advanced bladder cancer.
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Adcetris Approved as Initial Treatment for Stage III or IV Classical Hodgkin Lymphoma
FDA Approvals, News & Updates
Web Exclusives
— July 9, 2018
On March 20, 2018, the FDA approved a new indication for brentuximab vedotin (Adcetris; Seattle Genetics) as a first-line treatment, in combination with chemotherapy, for adults with untreated stage III or stage IV classical Hodgkin lymphoma. The FDA approved this indication using its priority review process and designated brentuximab vedotin as a breakthrough therapy.
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Blincyto Approved for Patients with B-Cell ALL and Minimal Residual Disease
FDA Approvals, News & Updates
Web Exclusives
— July 9, 2018
On March 29, 2018, the FDA accelerated the approval of a new indication for blinatumomab (Blincyto; Amgen) for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL) whose disease was in remission but was at risk for relapse because of minimal residual disease (MRD). The FDA granted blinatumomab orphan drug status for this indication.
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Rubraca Approved as Maintenance Treatment for Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
FDA Approvals, News & Updates
Web Exclusives
— July 9, 2018
On April 6, 2018, rucaparib (Rubraca; Clovis Oncology), a poly (ADP-ribose) polymerase (PARP) inhibitor, received a new indication by the FDA for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieved complete or partial response with platinum-based chemotherapy.
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Tagrisso Now Approved as First-Line Therapy for Patients with Metastatic NSCLC and EGFR Mutations
FDA Approvals, News & Updates
Web Exclusives
— July 9, 2018
On April 18, 2018, the FDA approved osimertinib (Tagrisso; AstraZeneca Pharmaceuticals) as first-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) and
EGFR
exon 19 deletions or exon 21
L858R
mutations, as detected by an FDA-approved test. The FDA used its priority review process, and designated osimertinib as a breakthrough therapy for this indication.
Read Article
Immune Checkpoint Inhibitors: Test Your Knowledge Level
By
Eileen Koutnik-Fotopoulos
Immunotherapy
,
Personalized Medicine
Web Exclusives
— July 6, 2018
Immune checkpoint inhibitors have changed the treatment landscape for many cancer types. These immunomodulatory antibodies target the PD-1, PD-L1, and CTLA-4 pathways to help restore immune responses against tumors.
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NCCN Issues First Guideline for Immunotherapy-Related Adverse Events
By
Wayne Kuznar
NCCN Guidelines
,
Side-Effects Management
Web Exclusives
— July 3, 2018
Read Article
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Home
Issues
Online First
Latest Issue
Issue Archive
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Personalized Medicine
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FDA Approvals, News & Updates
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Cholangiocarcinoma
View All Topics ›
Conference Correspondent
SABCS 2023 - HER2+ MBC
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Prostate Cancer Diagnostics Monthly Minutes
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AVBCC
Association for Value-Based Cancer Care
VBCM
Value-Based Care in Myeloma