November 13th 2025
The FDA has approved pertuzumab-dpzb (Poherdy) as a biosimilar to pertuzumab (Perjeta) in breast cancer, based on a review of various attributes, including safety and efficacy data.
November 11th 2025
FDA Grants Olaparib Priority Review in BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer
November 30th 2021Olaparib, which was granted priority review by the FDA, has been shown to improve invasive disease-free survival for patients with BRCA-mutated HER2-negative high-risk early breast cancer.
Eftilagimod Alpha Plus Paclitaxel Yields Overall Survival Benefit in Metastatic HR+ Breast Cancer
November 15th 2021Patients with hormone receptor–positive breast cancer in 3 separate subgroups showed an overall survival benefit when treated with eftilagimod alpha plus paclitaxel compared with the placebo.
FDA Approves Companion Diagnostic For Adjuvant Abemaciclib in High-Risk Early Breast Cancer
October 15th 2021The FDA has given the Ki-67 IHC MIB-1 pharmDx assay a companion diagnostic approval for detecting Ki-67 expression in patients with high-risk early breast cancer who are being considered for treatment with abemaciclib.