Aveo's tivozanib, now approved as Fotivda, will hit the market after years of setbacks

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Aveo Oncology won an FDA approval after years of setbacks. (Pixabay)

It’s been a long road to market for Aveo Oncology’s Fotivda, known for years as tivozanib, but the drug finally scored its FDA nod.  

On Wednesday, after numerous regulatory setbacks, Fotivda nabbed an FDA approval in third-line kidney cancer. The approval covers patients with relapsed or refractory renal cell carcinoma (RCC) who have received two prior systemic therapies.

A vascular endothelial growth factor tyrosine kinase inhibitor, Fotivda is the first drug specifically approved to treat that group of patients, Aveo said. 

Fotivda scored its approval based on a phase 3 study called Tivo-3, which compared the med to Bayer’s standard therapy Nexavar. Other trials provided safety data in more than 1,000 patients.

In the Tivo-3 trial, Fotivda fended off cancer progression for a median 5.6 months compared with 3.9 months for the Nexavar group. Some 18% of Fotivda patients achieved a pre-specified response to treatment, compared with 8% for the Nexavar patients.

But the Aveo drug didn't show it could help patients live longer: Fotivda posted overall survival of 16.4 months in the study, compared with 19.2 months for Nexavar.

Fotivda's safety record will be a selling point, SVB Leerink analyst Andrew Berens wrote in a Thursday note to clients, as will its status as the only approved med for third-line RCC.

The FDA rejected the medicine in first-line RCC back in 2013, and in 2019 the agency said the company wasn't ready to refile its medicine. Between then, the company entered a $4 million settlement with the Securities and Exchange Commission over allegations that didn’t disclose risks to its investors. 

RELATED: FDA tells Aveo no, again, for tivozanib as biotech tries to find yet another path forward 

Amid the struggles in the U.S., the drug won approval in Europe back in 2017. 

The approval wasn’t “fully anticipated” given the FDA’s prior rejection in first-line renal cell carcinoma, Berens wrote. Now, the focus for investors shifts from “regulatory risk to commercial execution,” he wrote.  

The company can likely “carve a meaningful niche” in its approved setting as it appears “generally safer and more tolerable” than Nexavar, and because Fotivda is the only drug specifically approved in the third-line setting, Berens wrote.

RELATED: Aveo's phoenix drug tivozanib rises up in Europe 

Aveo will put 65 full-time sales reps on the launch and the drug will carry a wholesale list price of $24,150 per month, Berens wrote. The analysts project $417 million in peak sales. 

Alongside its approval, Aveo said it promoted Mike Ferraresso to chief commercial officer. Ferraresso joined Aveo in December 2017 and most recently served as senior vice president, business analytics and commercial operations.