TKI 258 filed with FDA for renal cell carcinoma.
The Company’s NDA filing is supported by its prior PMA submission with the FDA for use of Dovitinib-DRP, the Company’s validated companion diagnostic for the drug, to select and treat RCC patients most likely to respond to dovitinib.
Dovitinib is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis, and is Allarity’s most advanced clinical therapeutic candidate. The drug has previously shown clinical activity in a number of cancer indications, including RCC, gastrointestinal stromal tumors (GIST), endometrial cancer, metastatic breast cancer, and hepatocellular carcinoma (HCC). The Company expects to further evaluate the therapeutic benefit of dovitinib in one or more of these additional indications, either as a monotherapy or in combination with other oncology therapeutics.
Related news and insights
Bristol Myers Squibb announced that Part A of the Phase III CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for patients with localized renal cell carcinoma (RCC) who have undergone full or partial removal of the kidney and who are at moderate or high risk of relapse, did not meet the primary endpoint of disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR).
Nektar Therapeutics and Bristol Myers Squibb announced that based on results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer, the companies have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo.
The UK NICE committee has published guidance recommending Opdivo (nivolumab), from BMS, with Yervoy (ipilimumab) within its marketing authorisation as an option for untreated advanced renal cell carcinoma in adults whose disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria and only if the company provides nivolumab with ipilimumab according to the commercial arrangement.