Oncology Venture has had a meeting with the FDA to discuss a potential path to approval for dovitinib used to treat Renal Cell Carcinoma (RCC) (kidney cancer), the current lead indication for the drug. The Company’s proposal is to seek approval based on “non-inferiority” against the already approved compound sorafenib (Bayer), based on prior Phase III trial results (by Novartis.
In the pre-NDA meeting and the subsequent Meeting Memorandum, the FDA indicated that they would accept the NDA filing if submitted, and provided additional guidance regarding the submission, including that the NDA would likely be referred to an Oncologic Drugs Advisory Committee (ODAC) for review and recommendation. The FDA provided input on the “non-inferiority” margin against sorafenib, which had not been pre-defined in the protocol for the prior Phase III trial in RCC, and discussed progression free survival (PFS) as an endpoint for “non-inferiority.” No other substantive issues were raised by the FDA. In addition, the FDA stated that no additional pre-clinical studies are required, no safety issues were raised, no additional pharmacokinetics (PK), pharmacology, and/or human toxicity studies are required, and no new manufacturing (CMC) requests are necessary.
Oncology Venture plans to use the data from the prior Phase III trial to prove that dovitinib is in fact “non-inferior” to sorafenib for the treatment of RCC, and expects that dovitinib will be approved by the FDA as a safe and efficacious drug beneficial to RCC patients as a third line treatment. However, the FDA’s feedback provides guidance only and the review process is unpredictable and may or may not lead to a formal approval.
Given the additional guidance, Oncology Venture now plans to file a New Drug Application (NDA) for the approval of dovitinib for the treatment of RCC late in the second half of 2020.