On July 23, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported regulatory updates from its interactions with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) regarding a potential path toward marketing authorization for vosaroxin as a treatment for acute myeloid leukemia (AML) in Europe and the United States (Press release, Sunesis, JUL 23, 2015, View Source;p=RssLanding&cat=news&id=2070668 [SID:1234506619]).
With respect to Europe, the company recently met separately with the Rapporteur (United Kingdom) and Co-Rapporteur (Netherlands) assigned to provide advice and guide the company through the Marketing Authorization Application (MAA) process.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Based on these substantive discussions, the company was encouraged to proceed with an MAA filing for the indication of relapsed/refractory AML in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company’s pivotal Phase 3 study of vosaroxin and cytarabine in adult patients with relapsed or refractory AML.
With respect to the United States, after conducting additional safety and efficacy analyses, the company recently met with the FDA. In light of not reaching statistical significance on the protocol-defined primary analysis of overall survival, Sunesis was informed that the Agency did not support a filing and encouraged the company to provide additional clinical evidence to support a future NDA submission.
Based on feedback from European and U.S. regulators, the company will place near-term focus on the MAA filing, which it will work to complete as expeditiously as possible, and will evaluate and refine its plan to gain marketing approval in the U.S.
"We are at once encouraged by our interactions with European regulators and disappointed with the outcome of our meeting with their U.S. counterparts," said Daniel Swisher, Chief Executive Officer of Sunesis. "Our belief, supported by many in the medical community, is that the VALOR outcomes for patients with high unmet needs were both compelling and an important step forward in addressing the enduring challenges of treating AML. We look forward to moving ahead with the submission of an MAA filing in Europe."
Mr. Swisher added: "Our confidence in vosaroxin stems not only from the outcomes seen in VALOR, but our ongoing investigator sponsored studies. It is our goal to leverage this body of data to determine a clinical and regulatory path forward for vosaroxin that is time and resource efficient, addresses the needs of patients with AML and maximizes our likelihood of regulatory and commercial success."