Aveo Pharmaceuticals’ troubled tivozanib is on the cusp of winning approval in Europe. Drug assessors in the region gave the thumbs-up to the tyrosine kinase inhibitor in kidney cancer, sending Aveo’s stock on a tear and teeing its partner up to bring the drug to market.
The positive opinion from Europe’s Committee for Medicinal Products for Human Use comes three years after a series of setbacks seemingly sunk tivozanib. Back then, the quickfire blows of a FDA rejection, back-to-back missteps in the clinic and the departure of partner Astellas decimated the stock price of Aveo and left tivozanib looking like a drug without a future.
In rejecting tivozanib, the FDA called data from Aveo’s pivotal TIVO-1 trial “uninterpretable and inconclusive.” But CHMP, reviewing data from the same clinical trial, has recommended tivozanib for approval in adults with advanced RCC who are who are VEGFR and mTOR pathway inhibitor-naïve and whose disease has progressed following cytokine therapy.
A formal approval from the European Commission will follow the CHMP recommendation.
The reversal in the fortunes of Aveo and tivozanib dates back to a licensing deal with EUSA Pharma late in 2015. That agreement gave EUSA the European rights to tivozanib in renal cell carcinoma for the knockdown fee of $2.5 million upfront. EUSA filed for approval in the indication the following year.
Aveo is in line to receive up to $394 million in milestones from EUSA. Some of those paydays are tied to the meeting of sales objectives. Tivozanib will need to elbow drugs such as Bayer’s Nexavar out of the way if it is to gain share. Nexavar is the incumbent and matched tivozanib in terms of overall survival in TIVO-1. But EUSA thinks its drug can still find a place in the market.
“Tivozanib has the potential to become an important new first-line therapy,” EUSA CEO Lee Morley said in a statement.
Despite the boost of the CHMP nod, Aveo remains a diminished force. But with its stock soaring as much as 70% in premarket trading and data from a phase 3 trial on the horizon, the biotech has both a rare piece of good news and the possibility of more to come.