FDA Approvals, News & Updates
FDA Approvals, News & UpdatesNewsworthyWeb Exclusives
In the past week, the US Food and Drug Administration (FDA) has released 2 public announcements related to the use of vaping products.
FDA Approvals, News & UpdatesLymphomaNewsworthy
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.
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.
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.
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.
Breast CancerFDA Approvals, News & UpdatesImmunotherapy
First Immunotherapy Approved for Patients with Advanced or Metastatic Triple-Negative Breast Cancer Expressing PD-L1
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.
Page 1 of 6
Results 1 - 10 of 59
Results 1 - 10 of 59