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FDA Approvals, News & Updates

Polivy a New Targeted Immunotherapy Approved for Patients with B-Cell Lymphoma
FDA Approvals, News & UpdatesLymphoma
In June 2019, the FDA approved a new type of immunotherapy called Polivy, for use in combination with other drugs, in patients with previously treated diffuse large B-cell lymphoma (DLBCL), offering new options for patients whose cancer has returned.
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.
Piqray New Treatment Approved for Metastatic Breast Cancer and PI3KCA Mutation
Breast CancerFDA Approvals, News & Updates
In May 2019, the FDA approved Piqray (alpelisib), the first PI3K inhibitor for the treatment of metastatic breast cancer with a PI3KCA mutation in postmenopausal women, and in men. An FDA spokesperson said it was the first treatment “to demonstrate a clinically meaningful benefit” for this type of breast cancer.
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.
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