FDA Refuses Aveo Oncology’s Kidney Cancer Drug Approval
As per recent reports, it has been revealed that Aveo Oncology has applied for the approval for its experimental kidney cancer drug known as tivozanib. After assessing the survival data provided by the company, the Food and Drug Administration has refused to give green signal to Aveo Oncology.
Aveo Oncology was of the view that the FDA has said that the data provided by them was inconsistent and was subject to doubt. Therefore, the drug cannot get approval for the treatment of people suffering from advanced renal cell carcinoma.
While providing detailed information, Aveo uncovered that the FDA has written in the letter that overall survival rate is inconclusive. A number of other doubts have also been raised due to which they cannot provide approval for the treatment.
They have asked the company to conduct additional trial and focus on the concerns that have been mentioned in the letter. The FDA has asked for the new dissolution data as well. "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, who is the President and Chief Executive of AVEO.
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