Complete Response Letters
AVEO Pharmaceuticals, Inc.: tivozanib hydrochloride
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 6, 2013
Act for (tivozanib hydrochloride) capsules, 1.0 mg or 1.5 mg.
CRL_NDA204408_20130606:p1:s15While the results of the primary endpoint of progression-free survival (PFS) statistically favored tivozanib [hazard ratio of 0.80; p value of 0.04], a potential 25% decrease in overall survival (OS) was also demonstrated [hazard ratio: 1.25; p value: 0.1].
CRL_NDA204408_20130606:p1:s29The inconsistent PFS and OS results and imbalance in post study treatments make the trial's results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval.
CRL_NDA204408_20130606:p1:s31We recommend that you perform an adequate and well-controlled randomized trial(s) of tivozanib using PFS as the primary endpoint and OS as a secondary endpoint.
CRL_NDA204408_20130606:p1:s34When your NDA is resubmitted, please include the revised specifications table for the drug product with the updated dissolution acceptance criterion.
CRL_NDA204408_20130606:p1:s438. Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA204408_20130606:p2:s16More Complete Response Letters
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