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FDA News

Erleada First Drug Approved for Patients with Nonmetastatic Prostate Cancer
FDA NewsNewsworthyProstate Cancer
On February 14, 2018, the FDA approved Erleada (apalutamide; from Janssen) for the treatment of patients with nonmetastatic, castration-resistant prostate cancer.
Verzenio Approved as Initial Treatment for Metastatic Breast Cancer
Breast CancerFDA NewsNewsworthy
The CDK4/CDK6 inhibitor Verzenio received a new indication, for use alone or in combination with an aromatase inhibitor, as initial therapy in women with HR-positive, HER2-negative advanced or metastatic breast cancer.
Blincyto First Drug Approved for ALL and the MRD Biomarker
Cancer BiomarkersFDA NewsLeukemiaNewsworthy
This is the first time the FDA has used minimal residual disease (MRD) as a biomarker to approve a specific treatment for patients with acute lymphoblastic leukemia (ALL).
FDA Approves First Direct-to-Consumer Genetic Test for 3 Types of BRCA Mutations in Men and Women
Cancer ScreeningFDA NewsNewsworthy
This first-ever direct-to-consumer genetic test can provide information on potential risks to individuals who may not have access to genetic screening, but the information may be misleading without feedback from experts.
Stivarga and Opdivo Newest Treatments for Liver Cancer
FDA NewsLiver CancerNewsworthy
In 2017, the FDA approved two new treatments for patients with hepatocellular carcinoma (HCC), Stivarga and Opdivo. Read about these new treatments for liver cancer.
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