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FDA Approvals, News & Updates

Tibsovo Approved for First-Line Treatment of Patients with Acute Myeloid Leukemia and IDH1 Mutation
FDA Approvals, News & UpdatesLeukemia
In May 2019, the FDA approved Tibsovo for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) and an IDH1 mutation, or for patients with AML who are unable to use intensive chemotherapy.
Balversa First Targeted Drug Approved for Metastatic Bladder Cancer with FGFR Genetic Alterations
Bladder CancerFDA Approvals, News & Updates
In April 2019, the FDA approved Balversa, an FGFR kinase inhibitor, for the treatment of adults with advanced or metastatic bladder cancer and an FGFR genetic alteration, as determined by an FDA-approved diagnostic test. This is the first FDA-approved targeted drug for patients with this specific genetic mutation.
First Immunotherapy Approved for Patients with Advanced or Metastatic Triple-Negative Breast Cancer Expressing PD-L1
Breast CancerFDA Approvals, News & UpdatesImmunotherapy
In March 2019, the FDA approved Tecentriq (atezolizumab), a PD-L1 inhibitor, in combination with Abraxane (paclitaxel protein-bound), for use in adults with locally advanced or metastatic triple-negative breast cancer whose tumors cannot be removed by surgery and express PD-L1, as identified by an FDA-approved test. This is the first FDA-approved immunotherapy for patients with advanced or metastatic triple-negative breast cancer.
Lonsurf Approved for Metastatic Gastric or Gastroesophageal Junction Cancer
FDA Approvals, News & UpdatesGastric Cancer
In February 2019, the FDA approved Lonsurf for the treatment of patients with metastatic gastric (stomach) cancer or gastroesophageal junction adenocarcinoma. This drug was previously approved only for patients with metastatic colorectal cancer.
FDA Approves Imbruvica plus Gazyva for First-Line Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
FDA Approvals, News & UpdatesLeukemia
This new chemotherapy-free combination of Imbruvica, a targeted therapy, plus Gazyva, a CD20-directed cytolytic antibody, was recently approved by the FDA as first-line treatment of adults aged 65 or older who are newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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