Aveo Oncology’s Fotivda Wins U.S. FDA Approval

 

The U.S. Food and Drug Administration (FDA) approved AVEO Oncology’s Fotivda (tivozanib) for adults with relapsed or refractory advanced renal cell carcinoma (RCC) in people who have had two or more previous systemic therapies. The FDA’s decision comes over three years after the European Union approved the drug in August 2017.

The drug is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). Company shares rocketed 89.1% at the news.

The company expects an official launch on March 31.

The approval was built on data from its Phase III TIVO-3 trial that compared Fotivda to sorafenib (Bayer’s Nexavar) in the reported indication. There were three other trials in RCC that included safety data from more than 1,000 trial volunteers.

Patients in TIVO-3 were randomized 1:1 to receive either Fotivda or sorafenib. The main efficacy endpoint was progression-free survival (PFS). Other efficacy endpoints included overall survival (OS) and objective response rate (ORR).

The median PFS was 5.6 months in the Fotivda arm compared to 3.9 months in the sorafenib cohort. Median OS was 16.4 and 19.2 months, respectively, and ORR was 18% and 8%, respectively.

The most common side effects were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia (difficulty speaking) , hypothyroidism, cough and stomatitis (inflammation of the mouth and lips). The most common grade 3 or 4 clinical laboratory anomalies were decreased sodium, increased lipase and decreased phosphate.

The recommended regimen is a 28-day cycle for the drug at 1.34 mg once a day with or without food for 21 days followed by 7 days off treatment until disease progression or unacceptable toxicity.

“Today’s approval of Fotivda provides a new tool for treating patients with kidney cancer who have relapsed or become refractory to two or more prior systemic therapies,” said Brian Rini, chief of clinical trials at Vanderbilt Ingram Cancer Center and principal investigator of the TIVO-3 trial. “With advances in RCC treatment, patients are living longer, increasing the need for proven, well tolerated treatment options in the relapsed or refractory setting. The TIVO-3 study is the first positive Phase III study in RCC patients who received two or more prior systemic therapies, and also the first Phase III RCC study to include a predefined population of patients who have received prior immunotherapy.”

RCC is a cancer in the tubules of the kidney. These tubules filter and clean blood, remove waste products and make urine.

AVEO is expected to report a quarterly loss of $0.40 per share in its upcoming report, a year-over-year change of -42.9%. Revenues are expected to be $3.03 million, an increase of 299.2% from the same quarter in 2020.

“We believe in Fotivda’s potential to provide a differentiated treatment option for the growing number of individuals in the U.S. with relapsed or refractory RCC, and today marks the culmination of many years of hard work and determination of many individuals to bring this therapy to patients,” said Michael Bailey, president and chief executive officer of AVEO. “With today’s approval, AVEO begins its journey as a commercial-stage company, a noteworthy accomplishment in our industry. On behalf of the entire AVEO team, I would like to thank all the patients, their families, and caregivers whose tireless efforts made this day possible.”