Relugolix May Become New Standard of Care for Advanced Prostate Cancer
June 1st 2020Relugolix (Relumina) demonstrated superiority over leuprolide (Lupron) in sustained testosterone (T)-suppression through 48 weeks, fast T-recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events (MACE) in patients with advanced prostate cancer.
FDA Grants Priority Review to CC-486 for the Treatment of Acute Myeloid Leukemia
May 1st 2020The FDA granted priority review to a new drug application for CC-486 for the maintenance treatment of adult patients with acute myeloid leukemia based on efficacy and safety results from the pivotal phase III QUAZAR AML-001 study.
FDA Grants Priority Review to Pembrolizumab Monotherapy for TMB-High Tumors
April 7th 2020The FDA granted priority review to pembrolizumab monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic TMB-high solid tumors who have progressed following prior treatment and who have no satisfactory alternative treatment options.
FDA ODAC Votes on Safety and Efficacy of Ramucirumab Plus Erlotinib for EGFR+ NSCLC
February 27th 2020The FDA Oncologic Drugs Advisory Committee voted 6 to 5 that ramucirumab plus erlotinib demonstrated a favorable benefit and risk profile for patients with untreated metastatic EGFR-positive non-small cell lung cancer.
FDA Grants Priority Review to KTE-X19 for Treatment of Mantle Cell Lymphoma
February 11th 2020The biologic license application is supported by data from the phase II ZUMA-2 trial, which is currently assessing the CAR T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.