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Web Exclusives published on December 2, 2019 in FDA Updates
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.
Web Exclusives published on December 2, 2019 in FDA Updates
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.
Web Exclusives published on November 25, 2019 in Lung Cancer
Chicago, IL—Treatment with the immune checkpoint inhibitor pembroliz­umab (Keytruda) dramatically improved 5-year survival for patients with advanced non–small-cell lung cancer (NSCLC) compared with expected survival in the preimmunotherapy era, according to the 5-year follow-up data from the phase 1b KEYNOTE-001 clinical trial. The study was presented at ASCO 2019 and was published simultaneously in the Journal of Clinical Oncology.
Web Exclusives published on November 25, 2019 in Ovarian Cancer
Ovarian cancer not only exacts a high mortality rate, but also affects the physical, mental, and financial health of those diagnosed with the disease.
Web Exclusives published on November 25, 2019 in Ovarian Cancer
Epidemiologic studies reveal population-based disparities in ovarian cancer morbidity and mortality rates.
Web Exclusives published on November 25, 2019 in Ovarian Cancer
Genetic, menstrual, and other factors have been associated with increased risk of ovarian cancer.
Web Exclusives published on November 25, 2019 in Ovarian Cancer
Current screening practices for ovarian cancer continue to result in late-stage diagnoses with consequent poor prognoses.
Web Exclusives published on November 25, 2019 in FDA Updates, In the News

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.

  • Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
  • Despite Some Positive Trends, Report Confirms Lung Cancer Remains the Deadliest Form of Cancer
  • Teva Will Resume Production of Vincristine in Response to Shortage
  • FDA Fast-Tracks Opdivo plus Yervoy Regimen for Treatment of Advanced Liver Cancer
  • FDA Grants Accelerated Approval to Brukinsa for Patients with Mantle-Cell Lymphoma
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