Treatment for Pheochromocytoma, Paraganglioma to Be Discontinued
Progenics Pharmaceuticals will stop producing Azedra (iobenguane I 131) injection due to a lack of commercial demand.
Progenics Pharmaceuticals will stop producing Azedra (iobenguane I 131) injection due to a lack of commercial demand.
Romidepsin is a histone deacetylase inhibitor indicated for the treatment of cutaneous T-cell lymphoma.
The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
In 2019, the FDA granted accelerated approval to Tecentriq, a PD-L1 blocking antibody, for unresectable locally advanced or metastatic TNBC.
The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
The approval was based on data from the open-label, multi-cohort phase 2 UNITY-NHL Trial.
The approval was based on data from the phase 2 DESTINY-Gastric01 trial.
The biosimilar has been approved for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis.
Results presented at the European Society for Medical Oncology Virtual Congress 2020showed significant improvements in the primary endpoints for the pembrolizumab group.