AVEO Oncology’s (AVEO) long journey to market tivozanib (Fotivda) has been approved. The drug, a kinase inhibitor, is approved for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
The main efficacy outcome measure was progression-free survival (PFS), assessed by a blinded independent radiology review committee. Other efficacy endpoints were overall survival (OS) and objective response rate (ORR).
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. The drug won approval in Europe in 2017.
AVEO’s market access includes increased sales rep resources focused on Fotivda and the selection of Biologics by McKesson and Onco360 as specialty pharmacy providers for the drug. Both specialty pharmacies are most often selected by manufacturers of oncology drugs based on their experience and ability to support the drugs in the market.
Biologics by McKesson is an independent specialty pharmacy with more than 25 years of experience connecting patients to life-changing medications in oncology and other rare and complex therapeutic areas.
Onco360 is the largest independent Oncology Pharmacy and clinical support services company in the country.
Takeaway: Biologics and Onco360 continue to solidify their positions as market-leading specialty pharmacy providers of oncology drugs