Aveo/Astellas’ Tivozanib Bests Nexavar, Barely, In Advanced Kidney Cancer
This article was originally published in The Pink Sheet Daily
Aveo/Astellas’ triple VEGF inhibitor tivozanib hit its progression-free survival endpoint of superiority over Onyx/Bayer’s Nexavar (sorafenib), but the question remains whether a three-month PFS advantage can confer first-line market superiority.
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FDA’s Oncologic Drugs Advisory Committee will consider the tyrosine kinase inhibitor for advanced renal cell carcinoma at a May 2 meeting. Aveo has attributed a negative overall survival trend in the TIVO-1 study to a crossover design and use of post-progression therapies among patients randomized to the comparator arm.
The Cambridge, Mass.-based company slows R&D and lays off 17% of its work force, but prepares to build a sales staff as it continues to reap auspicious data on the kidney cancer drug.
Astellas has tried to build oncology knowhow in the past six years, and while licensed compounds approach approval, Phase II in-house compounds may show whether it can be a global leader.