Oncology Venture (OV) recently revealed its new regulatory strategy and clinical development plan for one of highest priority assets: dovitinib. OV will seek marketing approval for dovitinib based on prior data from Novartis demonstrating non-inferiority versus Nexavar (sorafenib, Bayer) for metastatic renal cell carcinoma (mRCC). Moreover, the company plans to run clinical trials utilising the new drug response predictor (DRP) for the combination of dovitinib + PD-1/PD-L1 to identify mRCC patients highly likely to respond and file a supplemental new drug application (sNDA).Den vollständigen Artikel lesen ...