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FDA Approvals, News & Updates
FDA Approvals, News & Updates
FDA Approves Adakveo to Reduce Vaso-Occlusive Crises in Patients with Sickle-Cell Disease
By
Yvette Florio Lane
FDA Approvals, News & Updates
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In the News
Web Exclusives
On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease.
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November 11, 2019 — Oncology News & Updates
FDA Approvals, News & Updates
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In the News
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November 4, 2019 — Oncology News & Updates
Financial Toxicity
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Genomic Testing
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Head and Neck Cancer
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In the News
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Leukemia
Web Exclusives
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October 28, 2019 – Oncology News & Updates
FDA Approvals, News & Updates
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In the News
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Ovarian Cancer
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Solid Tumors
Web Exclusives
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Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News
By
Yvette Florio Lane
Breast Cancer
,
FDA Approvals, News & Updates
,
In the News
,
Multiple Myeloma
,
Pediatric Cancer
Web Exclusives
The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer.
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FDA on In Vitro Diagnostics, Vaping; Cost of Novel Treatments
FDA Approvals, News & Updates
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In the News
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NCCN Guidelines
Web Exclusives
FDA issues finalized guidelines for use of in vitro diagnostics in oncology drug trials and warnings on vaping; new findings report patients bear more costs when MBC treatment is not concordant with NCCN guidelines.
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FDA Approves Daratumumab Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone, for first-line treatment of multiple myeloma in patients eligible for autologous stem-cell transplant (ASCT). In June 2019, the FDA approved the combination of daratumumab plus lenalidomide (Revlimid) and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT. The FDA granted this application a priority review.
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Keytruda plus Lenvima Combo FDA Approved for Advanced Endometrial Carcinoma with No MSI-H or dMMR Tumors
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On September 17, 2019, the FDA accelerated the approval of a new combination of pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) for patients with advanced endometrial carcinoma that is not associated with microsatellite instability high (MSI-H) or mismatch repair–deficient (dMMR) tumors in patients whose disease progressed after systemic therapy and who are candidates for curative surgery or radiation. The FDA granted this application priority review and a breakthrough therapy designation.
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FDA Approved Erleada for Metastatic Castration-Sensitive Prostate Cancer
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On September 17, 2019, the FDA approved a new indication for apalutamide (Erleada; Janssen Biotech) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC). Apalutamide was initially approved in 2018 for the treatment of nonmetastatic castration-resistant prostate cancer. The FDA granted apalutamide priority review for the new indication.
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Turalio First FDA-Approved Systemic Therapy for Tenosynovial Giant-Cell Tumor
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On August 2, 2019, the FDA approved pexidartinib (Turalio; Daiichi Sankyo) capsules, a kinase inhibitor, for adults with symptomatic tenosynovial giant-cell tumor (TGCT), which is associated with severe morbidity or functional limitations, who are not candidates for surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT. The FDA granted pexidartinib a priority review and breakthrough therapy and orphan drug designations.
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Home
Issues
Online First
Latest Issue
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Personalized Medicine
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Conference Correspondent
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Prostate Cancer Diagnostics Monthly Minutes
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Value-Based Care in Myeloma