Genmab A/S and Seagen Inc. announced that the U.S. Food and Drug Administration granted accelerated approval to Tivdak (tisotumab vedotin-tftv), the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
The U.S. Food and Drug Administration granted full approval to Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The U.S. Food and Drug Administration approved Merck & Co. and Bayer AG’s heart failure drug Verquvo (vericiguat), an orally administered soluble guanylate cyclase stimulator.
The U.S. Food and Drug Administration approved MacroGenics Inc.’s drug Margenza in combination with chemotherapy for the treatment of an advanced type of breast cancer in patients who failed two or more prior therapies.
Immunomedics Inc.’s cancer drug Trodelvy, which received accelerated U.S. regulatory approval in April 2020, extended survival time in previously treated patients with an advanced form of breast cancer in a clinical trial.
The U.S. Food and Drug Administration removed a boxed warning about increased risk of leg and foot amputations with Johnson & Johnson’s diabetes drug Invokana.
The U.S. Food and Drug Administration approved Bristol Myers Squibb Co.’s combination therapy for previously untreated patients with a form of lung cancer, a much-needed boost as the company battles the dominance of Merck’s Keytruda.
Cambridge, Mass.-based Agios Pharmaceuticals announced that Tibsovo (ivosidenib) hit the primary endpoint in the Phase III ClarIDHy trial in patients with cholangiocarcinoma with an isocitrate dehydrogenase 1 mutation.