Now that positive results from Phase 3 clinical trials have been reported, the European Medicines Agency (EMA) has recommended approval for tivozanib through the EMA’s Committee for Medicinal Products for Human Use (CHMP), as treatment for advanced renal cell carcinoma (RCC). The drug, brand named Fotivda (AVEO Pharmaceuticals, Cambridge, MA) could receive a final decision for approval by late August or early September 2017. The US Food and Drug Administration approved the drug in 2013.
EUSA Pharma, a specialty pharmaceutical company based in Hemel Hempstead, UK, that has a distribution network in approximately 40 countries around the world, is poised to distribute tivozanib throughout Europe, South America, and South Africa.
“Tivozanib’s unique tolerability profile together with the longest progression-free survival, reported in a Phase 3 first line RCC study, have the potential to fill an unmet patient need for better tolerated treatment in this disease,” said Michael Bailey, president and chief executive officer of AVEO. Bailey also noted that the AVEO drug may be on track to become part of a future combination therapy in a Phase 2 trial with Opdivo (nivolumab, Bristol-Myers Squibb, New York, NY).
Bailey said that if the European Commission grants marketing approval for tivozanib, this outcome “would trigger a $4 million research and development reimbursement payment from EUSA (to AVEO)” with possible additional payments of up to 12 million.
The National Health Service in England and Wales has joined Scotland in approving the use of cabozantinib for advanced kidney cancer. The drug, marketed as Cabometyx in the United States, is the second drug for the company Exelixis (South San Francisco, CA).
In late June, researchers reported results of a head-to-head comparison of cabozantinib with everolimus (Afinitor, manufactured by Novartis Pharmaceuticals in East Hanover, NJ). They noted that cabozantinib improved rates of progression-free survival, objective response rate, and overall survival compared with everolimus among patients with advanced renal cell carcinoma regardless of nephrectomy status, according to Phase 3 results of the METEOR trial presented at the American Society of Clinical Oncology Annual Meeting.
An Investor’s Business Daily profile on Exelixis noted the company was confirming the effectiveness of its breakout compound for treating kidney cancer, posting first-time operating profit, and retiring the majority of its debt.
In late June, AstraZeneca and Hutchison China MediTech announced they had initiated a global late-stage clinical trial of the experimental drug savolitinib in a relatively rare type of kidney cancer. The Phase 3 study will test savolitinib in c-MET-driven papillary renal cell carcinoma.
AstraZeneca will pay China MediTech (Shanghai) $5 million, Reuters reported.
