Update on Investigational Drugs for Breast Cancer

According to the American Cancer Society current worldwide research is focused on preventing, detecting and treating breast cancer. There are a total of eighteen investigational drugs in the Pharmaceutical Pipeline Tracker. Eight of the eighteen have FDA Priority Designations.

Using the Pharmaceutical Pipeline Tracker’s new Search for Priority Designation by Indication feature, you’ll find the current set of eight investigational drugs targeting breast cancer to which the FDA has given Priority Designations: entinostat (Syndax), lurbinectedin (PharmaMar), pelareorep (Oncolytics Biotech), sacituzumab govitecan (Immunomedics/ Seattle Genetics), tavokinogene telseplasmid (Oncosec Medical), trastuzumab deruxtecan (AstraZeneca/ Daiichi Sankyo), tucatinib (Cascadian Therapeutics), and veliparib (AbbVie).

Although each have FDA Priority Designations, none have PDUFA Dates at this time. Here’s the latest on each from our News and Analysis section:

Entinostat - Syndax is evaluating entinostat in combination with exemestane in a Phase III trial of patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer. The drug has a FDA Breakthrough Therapy Priority Designation. 

 Lurbinectedin - PharmaMar has a phase III lurbinectedin trials examining the change in progression-free-survival, overall survival and overall response rate in the treatment of platinum-resistant ovarian cancer and platinum-resistant small-cell lung cancers. Lurbinectedin has an Orphan Drug Priority Designation.

Pelareorep - Oncolytics has an ongoing Phase II trial examining palareorep plus paclitaxel vs paclitaxel monotherapy in advanced/metastatic breast cancer. The drug has Fast Track and Orphan Drug Priority Designations.

Sacituzumab govitecan – Although the FDA gave this investigational drug a Breakthrough Therapy Priority Designation in the treatment of triple negative breast cancer, the FDA rejected sacituzumab govitecan on 1/17/2019 due data integrity issues with manufacturing the drug. Immunomedics has an ongoing Phase III trial evaluating sacituzumab govitecan.

Tavokinogene telseplasmid – The FDA has given this combination Fast Track and Orphan Drug Priority Designations. It provides a pulsed electrical field to cells from a hand-held applicator which temporarily increases the porosity of the cell membranes and allows DNA IL-12 to pass into the cell, which triggers production of IL-12 protein, which kills cancer cells by an immune response.
Trastuzumab deruxtecan – this antibody drug conjugate has Fast Track and Breakthrough Therapy Priority Designations, is a HER2 targeting antibody drug conjugate with a humanized anti-HER2 antibody, cleavable peptide-based linker, and topoisomerase I inhibitor payload. 

Tucatinib - The FDA designate tucatinib an Orphan Drug. A Phase II trial of tucatinib in combination with capecitabine and/or trastuzumab in patients with metastatic HER2+ breast cancer is ongoing. 
 
Veliparib - Ongoing trials for veliparib include trials in patients with advanced BRCA-mutant, HER2-negative breast cancer and advanced, non-squamous NSCLC in current or former smokers. The FDA designate veliparib an Orphan Drug. 
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Subscribe to the Pharmaceutical Pipeline Tracker to view the complete monographs of these eight and the other ten investigational drugs targeting breast cancer.