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May 2018 – Cancer Biomarkers and Molecular Testing

Verzenio Approved as Initial Treatment for Metastatic Breast Cancer
Breast CancerFDA Approvals, News & UpdatesNewsworthy
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
BiomarkersFDA Approvals, News & UpdatesLeukemiaNewsworthy
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).
Erleada First Drug Approved for Patients with Nonmetastatic Prostate Cancer
FDA Approvals, News & UpdatesNewsworthyProstate Cancer
On February 14, 2018, the FDA approved Erleada (apalutamide; from Janssen) for the treatment of patients with nonmetastatic, castration-resistant prostate cancer.
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