FDA 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. Read More ›
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. Read More ›
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. Read More ›
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). Read More ›
In July 2018, the FDA approved Tibsovo (ivo-sidenib; from Agios Pharmaceuticals), the first IDH1 inhibitor, for the treatment of adults with relapsed (returning) or refractory (not responding to treatment) acute myeloid leukemia (AML) and a susceptible IDH1 genetic mutation. Read More ›