Camcevi is a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, a gonadotropin-releasing hormone agonist.
The approval was based on data from the phase 3 ZUMA-7 trial.
Fyarro has also been added to the NCCN Guidelines as the only preferred treatment regimen for malignant PEComa.
Maribavir is an orally bioavailable anti-CMV compound that targets and inhibits the UL97 protein kinase and its natural substrates.
The approval is supported by data from the phase 3 BEACON CRC trial in adults with BRAF V600E mutation-positive metastatic colorectal cancer with disease progression.
The application is supported by data from the phase 3 RATIONALE 302 trial.
The approval was based on data from the phase 3 ASPEN trial.
In 2019, the FDA granted accelerated approval to Tecentriq, a PD-L1 blocking antibody, for unresectable locally advanced or metastatic TNBC.
The approval was based on data from an open-label phase 2 study which evaluated the efficacy and safety of Welireg in patients with von Hippel-Lindau-associated renal cell carcinoma and other VHL-associated tumors.
Nab-sirolimus is an mTOR inhibitor bound to human albumin.
