AVEO Oncology (AVEO) Receives CRL from FDA for Tivozanib
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AVEO Oncology (Nasdaq: AVEO) has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) informing the company that the FDA will not approve in its present form the New Drug Application (NDA) for AVEO’s investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).
In the letter, the FDA stated that the inconsistent progression-free survival and overall survival results and imbalance in post-study treatments make the TIVO-1 results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval, and recommended that AVEO conduct an additional clinical study to support approval of tivozanib for the treatment of advanced RCC. The FDA also stated that the proposed dissolution acceptance criterion was not supported by the provided dissolution data, and would need to be updated and resubmitted.
“In follow up to our conference call last week regarding AVEO’s restructuring, we will convene a conference call tomorrow to discuss the Complete Response letter and recent ODAC meeting,” said Tuan Ha-Ngoc, president and chief executive of AVEO. “We hope this will be an opportunity to address questions our investors may have about the FDA’s review of the tivozanib NDA in RCC.”
In the letter, the FDA stated that the inconsistent progression-free survival and overall survival results and imbalance in post-study treatments make the TIVO-1 results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval, and recommended that AVEO conduct an additional clinical study to support approval of tivozanib for the treatment of advanced RCC. The FDA also stated that the proposed dissolution acceptance criterion was not supported by the provided dissolution data, and would need to be updated and resubmitted.
“In follow up to our conference call last week regarding AVEO’s restructuring, we will convene a conference call tomorrow to discuss the Complete Response letter and recent ODAC meeting,” said Tuan Ha-Ngoc, president and chief executive of AVEO. “We hope this will be an opportunity to address questions our investors may have about the FDA’s review of the tivozanib NDA in RCC.”
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