FDA to Quickly Review sNDA for Enzalutamide in nmCSPC With High-Risk BCR
August 23rd 2023The metastasis-free survival benefit of enzalutamide, and other efficacy and safety data are now under FDA review for the potential approval of the drug for patients with non-metastatic castration-sensitive prostate cancer.
BMI May Positively Impact the Pharmacodynamics of Palbociclib in Patients With eBC
August 15th 2023According to Erica Mayer, MD, MPH, an analysis of the PALLAS study that patients with a higher BMI appeared to have less toxicity from the CDK4/6 inhibitor, palbociclib, and fewer cases of early discontinuation due to toxicity.
FDA Approves Niraparib Plus Abiraterone Acetate and Prednisone for BRCA+ mCRPC
August 11th 2023Results from the phase 3 MAGNITUDE study have led to a quick FDA decision on the future of a dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer.
REZILIENT3: Evaluating Zipalertinib/Chemo in EGFR Exon20ins+ NSCLC
August 7th 2023Determining the safety and efficacy of zipalertinib combined with chemotherapy for patients with EGFR exon 20 insertion mutation-positive non–small cell lung cancer are the key goals of the newly-launched phase 3 REZILIENT3 study.
FDA Approves Dostarlimab Plus Chemotherapy in dMMR/MSI-H Advanced Endometrial Cancer
July 31st 2023FDA approval has been granted to dostarlimab in combination with chemotherapy for the treatment of patients with mismatch repair deficient and microsatellite instability-high primary advanced or recurrent endometrial cancer.