AVEO Receives FDA Update For Tivozanib In Colorectal Cancer

(RTTNews) - The oncology unit of biopharmaceutical company AVEO Pharmaceuticals, Inc. (AVEO) confirmed Thursday that it received written feedback from the U.S. Food and Drug Administration regarding a potential pivotal study for tivozanib in the treatment of NRP-1 low colorectal cancer (CRC).

In response to questions from AVEO regarding a proposed pivotal phase 3 trial of tivozanib in CRC, the FDA suggested that the work be continued on the development of its biomarker assay to address variability between assays presented, and that, at present, "insufficient data exists to determine the appropriateness of this [NRP-1 low] subgroup" for the proposed phase 3 study.

This feedback is consistent with the Company's current clinical strategy and discussions with cancer research cooperative groups.

The feedback is based on the results from the BATON-CRC study and the company's ongoing assay development efforts that were presented to the FDA.

The BATON-CRC study is a 265 patient randomized trial exploring the combination of mFOLFOX6 and tivozanib or bevacizumab as first-line treatment in patients with advanced metastatic CRC.

AVEO also plans to evaluate options to confirm the activity of tivozanib and FOLFOX in NRP-1 low CRC through a prospectively defined, randomized Phase 2 study, while continuing to work on the development of a commercially viable assay.

Tivozanib is an oral, potent, selective inhibitor of vascular endothelial growth factor tyrosine kinase inhibitor or VEGF TKI with a long half-life and activity against all three VEGF receptors. Tivozanib has been evaluated in several tumors types, including renal cell, colorectal and breast cancers.