New Drugs Approved in 2020
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Breast Cancer
Novel Breast Cancer Treatment Gains Approval
Phase 3 trial results showed that the objective response rate for margetuximab plus chemotherapy was 22% vs 16% for trastuzumab plus chemotherapy.
MPR Weekly Dose Podcast Episode 59
The latest on the vaccine development from Moderna, and BioNTech and Pfizer as they release more trial data; An at-home diagnostic test is approved; Keytruda gains expanded approval; And all the rest of the drug news from this past week.
Keytruda Approved for Triple-Negative Breast Cancer
The approval was based on data from the phase 3 KEYNOTE-355 trial that pembrolizumab plus chemotherapy in adults with locally recurrent inoperable or metastatic TNBC, who had not been previously treated with chemotherapy in the metastatic setting.
Palbociclib Misses Primary End Point in Early Breast Cancer Trial
German Breast Group (GBG) and Pfizer announced that its phase 3 trial of palbociclib did not meet the primary end point for the treatment of women with HR+, HER2- early breast cancer who have residual invasive disease after completing neoadjuvant chemotherapy.
Abemaciclib Beneficial for HR+, HER2− Early Breast Cancer
Significant improvements seen in rates of invasive disease-free survival, distant recurrence-free survival.
FDA: Efficacy, Safety Concerns With Breast Cancer Combo Therapy
Findings showed atezolizumab in combination with paclitaxel did not meet statistical significance for progression free survival and also demonstrated a negative trend in overall survival.
Gadavist Imaging Bulk Package Approved for Multi-Patient Dosing
Gadavist® Imaging Bulk Package is supplied as 604.72mg/mL of gadobutrol in 30mL and 65mL multidose containers.
Trial Assessing Atezolizumab in Triple-Negative Breast Cancer Misses End Point
Findings showed that the study did not meet statistical significance for progression free survival.
MPR Weekly Dose Podcast Episode 41
This week on the Pod: The FDA issues guidance for COVID-19 vaccine development; Accuracy in COVID-19 antibody testing; How statins may improve outcomes for hospitalized COVID-19 patients; and in non-COVID-related news there’s a new drug approvals in breast cancer and Dravet syndome.
