FDA Approvals, News & Updates
Late last year, the PARP inhibitor Zejula was approved by the FDA for patients with HRD mutation associated with advanced ovarian, fallopian tube, or primary peritoneal cancer, offering a new treatment option for women with these types of cancer. Read More ›
Late in 2019, the FDA approved the combination of immunotherapy plus chemotherapy as the first-line treatment for patients with non–small-cell lung cancer that does not harbor EGFR or ALK mutations, which are often associated with lung cancer. Read More ›
In the past week, the US Food and Drug Administration (FDA) has released 2 public announcements related to the use of vaping products. Read More ›
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. Read More ›
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. Read More ›
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. Read More ›