Product Sponsor Goal PDFUA Date Indication
Sacituzumab govitecan* (IMMU-132) 2020-06-02 Antibody drug conjugate (ADC) for treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease
Opdivo (nivolumab) and Yervoy (ipilimumab) 2020-05-15 Combination immuno-oncology regimen of the PD-1 checkpoint inhibitor and a low dose of the CTLA4 inhibitor for first-line treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) patients with no EGFR or ALK genomic tumor aberrrations, based on part 1 of the Phase III CheckMate-227 trial
Xpovio (selinexor) 2020-06-23 New indication for the oral selective inhibitor of nuclear export (SINE) compound for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two prior multi-agent therapies and who are ineligible for stem cell transplantation, including CAR-T (chimeric antigen receptor modified T cell) therapy
Lynparza (olaparib) 2020-05 New indication for the PARP inhibitor for use in combination with bevacizumab (Genentech’s Avastin) for maintenance treatment of ovarian cancer patients who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab
Keytruda (pembrolizumab) 2020-06-29 New indication for the PD-1 inhibitor immuno-oncologic for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation