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FDA Approvals, News & Updates

Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
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. Read More ›

Tabrecta Approved for NSCLC with MET Biomarker
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. Read More ›

Zejula Now Approved as First-Line Maintenance Therapy in All Patients with Ovarian 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. Read More ›

First-Line Treatment with Calquence Produces Long-Term Responses in Patients with Chronic Lymphocytic Leukemia

Trodelvy New Therapy Approved for Triple-Negative Breast Cancer
In April, 2020, the FDA approved Trodelvy for the treatment of adults with metastatic triple-negative breast cancer after 2 or more previous therapies. Read More ›

Pemazyre First Therapy Approved for Cholangiocarcinoma with FGFR2 Biomarker
In April, the FDA approved Pemazyre, the first targeted drug for patients with advanced cholangiocarcinoma and a biomarker called FGFR2 gene fusion. Read More ›

Tukysa Approved for Breast Cancer and HER2 Biomarker
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. Read More ›

Jelmyto First FDA-Approved Therapy for Low-Grade Upper-Tract Urothelial 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. Read More ›

Brukinsa FDA Approved for Mantle-Cell Lymphoma
In November 2019, the FDA approved the second Bruton tyrosine kinase inhibitor for the treatment of adults with mantle-cell lymphoma (a type of non-Hodgkin lymphoma) who have received at least 1 previous therapy. Read More ›

Calquence Approved for Chronic Lymphocytic Leukemia
In November 2019, the FDA approved a new treatment, Calquence, for patients with relapsed or refractory CLL or SLL. Read More ›

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