Developer: Aveo Pharmaceuticals
Partner: Astellas Pharma
Lead indication: Renal cell carcinoma
Key date: NDA submission expected in Q3
Aveo Pharmaceuticals ($AVEO) brought in 2012 with positive data from a pivotal trial of its lead drug tivozanib, bolstering its case that the drug could become a safe and effective next-generation treatment for kidney cancer known as renal cell carcinoma. Though the data failed to inspire some investors, the Cambridge, MA-based company is on track to file its application this summer for an FDA nod.
The market for drugs to treat patients with metastatic RCC is somewhat crowded, and the FDA had approved 7 drugs for the kidney cancers since 2005 as of late January. Aveo has trumpeted that tivozanib could offer some advantages for patients with the disease, potentially providing the company and partner Astellas Pharma with an edge in the market if the drug gets approved.
Right now, industry watchers are awaiting detailed data from Aveo's Phase III TIVO-1 trial this June during the big American Society of Clinical Oncology (ASCO) annual meeting. Those data will provide a clearer picture of how tivozanib, a blocker of all three VEGF receptors, stacks up against comparable meds such as Onyx Pharmaceuticals' Nexavar and Pfizer's ($PFE) Sutent. Pfizer also grabbed an FDA approval for another VEGF inhibitor called axitinib or Inlyta in January as a second-line treatment for advanced RCC.
Aveo wants to break into the advanced RCC market with tivozanib as a first-line therapy for the aggressive kidney cancers. In its 517-patient study TIVO-1, the company showed that patients on its drug survived for a median of 11.9 months without their cancer getting worse compared with a median of 9.1 months in patients on Nexavar. Aveo is building a case that its drug offers low side effects for a drug of its ilk, something that could make a difference in the marketplace.