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Issues
2019
October 2019, Vol 10, No 5
October 2019, Vol 10, No 5
Oral Parity Laws Could Reduce Disparities in Cancer Care
By
Chase Doyle
Disparities in Oncology
October 2019, Vol 10, No 5
San Diego, CA—Great progress has been made in the fight against cancer, but not all patients have benefited equally. Disparities exist among specific populations in terms of survival and cancer-related mortality, incidence and prevalence, as well as adverse health conditions, according to Karen M. Winkfield, MD, PhD, Director, Office of Cancer Health Equity, Wake Forest Baptist Medical Center Comprehensive Cancer Center, Winston-Salem, NC. Dr Winkfield discussed the topic at the 2019 ASCO Quality Care Symposium.
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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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Inrebic Receives FDA Approval for Adults with Myelofibrosis
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene/Impact Biomedicines), an oral kinase inhibitor, for adults with intermediate-2 or high-risk primary or secondary—post–polycythemia vera (PV) or post–essential thrombocythemia (ET)—myelofibrosis, a rare bone marrow disorder. The FDA granted fedratinib priority review and an orphan drug designation.
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Rozlytrek Third FDA-Approved Tumor-Agnostic Drug and Second Treatment for Patients with NTRK Fusion Tumors
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On August 15, 2019, the FDA accelerated the approval of entrectinib (Rozlytrek; Genentech), an oral kinase inhibitor, for the treatment of adults and adolescents whose cancer involves neurotrophic tyrosine receptor kinase (
NTRK
) gene fusion that has no effective treatments. The FDA granted entrectinib a priority review and breakthrough therapy and orphan drug designations. This is the third cancer drug approved by the FDA based on a common biomarker and the second drug for patients with
NTRK
gene fusion.
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Adding CDK4/6 Inhibitor to Endocrine Therapy Improves Survival in Advanced Breast Cancer: New Standard of Care
By
Phoebe Starr
ESMO 2019
October 2019, Vol 10, No 5
Barcelona, Spain—Late-breaking data from 2 clinical trials presented at ESMO 2019 will likely change the treatment paradigm for pre- or postmenopausal women with hormone receptor (HR)-positive, HER2-negative breast cancer, regardless of menopausal status. The MONALEESA-3 study and the MONARCH-2 study showed an improved overall survival (OS) with the addition of the CDK4/6 inhibitor ribociclib (Kisqali) or abemaciclib (Verzenio) to endocrine therapy as first- or second-line therapy. The results were presented at the Presidential Session of the meeting.
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Oral Cancer and Sex in the Era of HPV Infection
By
Meg Barbor, MPH
Head and Neck Cancer
October 2019, Vol 10, No 5
San Francisco, CA—The increasing rate of infection with the human papillomavirus (HPV) in the United States has changed the field of head and neck cancer, or oral cancer, and HPV infection now causes a growing majority (70%-90%) of oropharyngeal squamous-cell carcinomas. As its incidence is rising, so is patients’ curiosity about what sets this cancer apart from other malignancies.
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Nubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer HealthCare), an oral androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). This approval was based on a multicenter, double-blind, placebo-controlled clinical trial known as ARAMIS. The FDA granted this application priority review.
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Home
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Personalized Medicine
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