The European regulators have approved Aveo Pharmaceuticals’ infamous tyrosine kinase inhibitor drug Tivozanib late last week.
Europe has among the highest incidence rates of kidney cancer in the world, with approximately 115,000 people being diagnosed in 2012.
And the green light from Europe’s Committee for Medicinal Products for Human Use comes three years after major setbacks that almost buried the drug and the industry decided to write the drug off.
Earlier, the FDA called data from Aveo’s pivotal TIVO-1 trial of the drug “uninterpretable and inconclusive.” Also the drugs’ unfortunate missteps in the clinic have forced the partners’ Astellas departure which resulted in the downward spiral of the company’s stocks.
Presently, the European Medicines Agency (EMA) said experts at its Committee for Medicinal Products for Human Use (CHMP) has backed the oral, once-daily drug for marketing approval as a first-line treatment for advanced renal cell carcinoma, or kidney cancer. The EMA is also backing this drug for the treatment of adult patients with advanced kidney cancer.
Aveo, in a 2015 licensing deal with the EUSA Pharma had handed it the rights to tivozanib for treatment of renal cell carcinoma for the knockdown fee of $2.5 million upfront. Currently thanks to
the approval of the drug to market in Europe, Aveo is in line to receive up to $394 million in milestones from EUSA.However, Tivozanib will need to elbow out drugs such as Bayer’s Nexavar to gain market space.
Nexavar is the incumbent and matched tivozanib in terms of overall survival in TIVO-1.
“Tivozanib has the potential to become an important new first-line therapy,” said EUSA CEO Lee Morley reflecting how the company believes the drug will find its place in the market.
