Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 335

AVEO Oncology Announces Regulatory Update for Tivozanib in Renal Cell Carcinoma

Posted by fidest press agency su giovedì, 7 novembre 2019

AVEO Oncology (NASDAQ: AVEO) today provided a regulatory update following a meeting with the U.S. Food and Drug Administration (FDA) to discuss results from the August 2019 overall survival (OS) analysis of the TIVO-3 trial and the Company’s proposal to proceed with a New Drug Application (NDA) for tivozanib.The Company previously announced that the TIVO-3 trial met its primary endpoint of demonstrating a significant improvement in PFS. The study also demonstrated a significant improvement in the secondary endpoint of overall response rate. The August 2019 analysis of the secondary endpoint of OS was the second prespecified interim OS analysis of the TIVO-3 trial, and showed an updated OS hazard ratio (HR) of 0.99 at two years from the last patient enrolled in the study.In the FDA’s preliminary feedback, based on its assessment of the totality of evidence presented to date, the FDA recommended that the Company not submit an NDA at this time. The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib. The FDA noted that the Company’s current interim OS results do not abrogate the FDA’s concerns over detriment and that those results may worsen with final analysis at 263 events, and that the median OS for tivozanib is worse than that of sorafenib.In view of the changing first-line treatment landscape as well as the FDA’s continued concerns, the Company informed the FDA that it intends to narrow its proposed indication to relapsed/refractory RCC. At the meeting, the FDA acknowledged AVEO’s responses and reiterated its concerns about the survival information and the totality of data. The FDA noted that the choice to submit the data is the Company’s, and that a discussion with the Oncologic Drug Advisory Committee will likely be required. The FDA said that if AVEO wishes to proceed with a revised OS analysis in June 2020, AVEO should submit an updated statistical analysis plan (SAP) with a planned OS update based on the projected number of events at that time.AVEO intends to submit to the FDA an update to the SAP for the final OS analysis consistent with these discussions, followed by an NDA submission in the first quarter of 2020. AVEO expects to report the final OS analysis in June 2020 based on a May 1, 2020 cutoff, at which point the Company estimates that the study will have reached approximately 263 OS events, as discussed with the FDA. The FDA and the Company agreed that if the final analysis yields an OS HR above 1.00, the Company will withdraw its NDA application.


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