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FDA Approvals, News & Updates

Blincyto First Drug Approved for ALL and the MRD Biomarker
Cancer 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).
FDA Approves First Direct-to-Consumer Genetic Test for 3 Types of BRCA Mutations in Men and Women
Cancer ScreeningFDA Approvals, News & UpdatesNewsworthy
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 Approvals, News & UpdatesLiver 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.
Alecensa a New First-Line Treatment for Lung Cancer with ALK Mutation
FDA Approvals, News & UpdatesLung CancerNewsworthy
In November 2017, the FDA approved Alecensa for the treatment of all patients with metastatic non–small-cell lung cancer (NSCLC) and ALK mutation.
Calquence Newest Treatment Approved for Mantle-Cell Lymphoma
FDA Approvals, News & UpdatesLymphomaNewsworthy
In October 2017, the FDA accelerated the approval of Calquence for the treatment of adults with mantle-cell lymphoma who have received at least 1 previous therapy.
Verzenio a New Targeted Therapy Approved for Metastatic Breast Cancer
Breast CancerFDA Approvals, News & UpdatesNewsworthy
Read about Verzenio, which was approved by the FDA in 2017, in combination with fulvestrant, for treatment of women with HR-positive, HER2-positive, HER2-negative advanced, or metastatic breast cancer that progressed after endocrine therapy.
Lynparza Approved as Maintenance Treatment for Ovarian Cancer
FDA Approvals, News & UpdatesGynecologic CancersNewsworthyOvarian Cancer
In August 2017, the FDA approved Lynparza tablets for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or peritoneal cancer who had a response to platinum-based chemotherapy.
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