On March 20, 2020 Oncology Venture A/S ("OV" or the "Company") reported that it has received feedback from its recent pre-NDA meeting with the U.S. FDA regarding a potential path to approval for Dovitinib, one of its top priority programs (Press release, Oncology Venture, MAR 20, 2020, View Source [SID1234555730]).
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The Company attended a pre-NDA meeting with the U.S. Food and Drug Administration (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 3 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)1 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 3 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 3 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 Aplication (NDA) for the approval of Dovitinib for the treatment of RCC late in the second half of 2020.
Dovitinib, a pan-tyrosine kinase inhibitor (TKI) originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of Renal Cell Carcinoma. Annual sales of Sorafenib, under the trade name Nexavar, were approximately USD $715 million in 2018. The global RCC market is projected to grow to USD $6.3 billon by 2022. In addition to the RCC market, Dovitinib has promising potential as a monotherapy in a number of other indications, including metastatic breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.
Steve Carchedi, CEO of Oncology Venture, stated "We are excited to move towards U.S. submission of our first oncology portfolio asset and appreciate FDA guidance in the filing process. Mr. Carchedi further noted that "Renal Cell cancer continues to have a high unmet need and we hope that Dovitinib, alone or together with a DRP companion diagnostic that we are validating for the drug, will provide patients with a more effective treatment."