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FDA Approvals, News & Updates

FDA NEWs
FDA Approvals, News & Updates
On August 5, 2020, the FDA accelerated the approval of Blenrep (belantamab mafodotin-blmf; from GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 previous therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
FDA Approvals, News & Updates
In June, the FDA approved Zepzelca as the newest treatment for patients with metastatic small-cell lung cancer, an uncommon type of lung cancer with few treatment options.
Trodelvy New Therapy Approved for Triple-Negative Breast Cancer
Breast CancerFDA Approvals, News & Updates
In April, 2020, the FDA approved Trodelvy for the treatment of adults with metastatic triple-negative breast cancer after 2 or more previous therapies.
Tabrecta Approved for NSCLC with MET Biomarker
BiomarkersFDA Approvals, News & Updates
In May 2020, the FDA approved Tabrecta, a new targeted therapy for the treatment of patients with metastatic non–small-cell lung cancer that is associated with the MET biomarker.
Zejula Now Approved as First-Line Maintenance Therapy in All Patients with Ovarian Cancer
FDA Approvals, News & UpdatesOvarian Cancer
In April 2020, the FDA approved Zejula for long-term maintenance therapy for all patients with advanced ovarian cancer, regardless of any gene mutations.
Pemazyre First Therapy Approved for Cholangiocarcinoma with FGFR2 Biomarker
CholangiocarcinomaFDA Approvals, News & Updates
In April, the FDA approved Pemazyre, the first targeted drug for patients with advanced cholangiocarcinoma and a biomarker called FGFR2 gene fusion.
Tukysa Approved for Breast Cancer and HER2 Biomarker
Breast CancerFDA Approvals, News & Updates
Another drug approved by the FDA in April, Tukysa, a kinase inhibitor, is a new treatment option for the treatment of patients with advanced HER2-positive breast cancer.
Bladder CancerFDA Approvals, News & UpdatesUrothelial Cancer
In April 2020, the FDA approved Jelmyto as the first treatment for low-grade upper-tract urothelial cancer, a rare cancer that affects the urinary system.
FDA and CDC Investigate Outbreak of Vaping-Related Illness
FDA Approvals, News & UpdatesNewsworthy
In the past week, the US Food and Drug Administration (FDA) has released 2 public announcements related to the use of vaping products.
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