|Delcath Confirms FDA Panel Voted 16-0 Against Melblez Kit; AVEO, Astellas Confirm Unfavorable Vote by FDA on Tivozanib|
|By Staff and Wire Reports|
|Thursday, 02 May 2013 19:15|
Delcath Systems, Inc. (NASDAQ: DCTH) announced that the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez^TM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) for the treatment of patients with unresectable ocular melanoma metastatic to the liver do not outweigh the risks associated with the procedure.
The FDA is not bound by the recommendation of its advisory committee, but will consider the committee's guidance as it evaluates the Melblez Kit New Drug Application (NDA). The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA's review and decision regarding approval of the Melblez Kit NDA is September 13, 2013.
"As we conveyed during the presentation to the ODAC, we believe our clinical trial data support Melblez Kit as an effective treatment option offering clinical benefits to patients with unresectable metastatic ocular melanoma in the liver" said Eamonn P. Hobbs, President and CEO of Delcath Systems. "While we were disappointed in today's outcome, we will continue to work closely with the FDA throughout its ongoing evaluation of Melblez Kit. We remain committed to providing access to this promising new treatment for patients who have few choices with regard to treatments."
AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. reported the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) voted that the application for investigational agent tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial (13 to 1, 0 abstentions).
“While we are disappointed with the outcome of the ODAC vote, we remain confident in the efficacy, safety and tolerability of tivozanib in RCC patients,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “We are committed to the RCC patient community and will work closely with the FDA to address the issues discussed by the panel today as the Agency continues its ongoing review of the New Drug Application for tivozanib.”
The ODAC provides the FDA with independent expert advice and recommendations. The FDA is not bound by the Committee's guidance, but its input will be considered by the Agency in its review of the tivozanib New Drug Application (NDA), which was submitted by AVEO on September 28, 2012. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is expected to be complete by July 28, 2013.
The ODAC reviewed findings from a total of 17 trials involving more than 1,000 patients, including the global Phase 3 TIVO-1 (TIvozanib Versus SOrafenib in 1st line Advanced RCC) trial, a randomized superiority-designed pivotal trial evaluating the efficacy and safety of tivozanib compared to sorafenib, an approved targeted agent, in 517 patients with advanced RCC. In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival, the primary endpoint of the study, and a favorable tolerability profile when compared to sorafenib.
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AVEO Oncology (NASDAQ: AVEO) today announced that NASDAQ halted trading of AVEO common stock this morning, May 2, 2013. The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) meets today to discuss the New Drug Application (NDA) for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).
AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that the application for investigational agent tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial (13 to 1, 0 abstentions).
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Life Technologies Corporation (NASDAQ: LIFE) today announced results for its first quarter ended March 31, 2013. Revenue for the first quarter was $963 million, an increase of 2.5 percent over the $939 million reported for the first quarter of 2012.
Janssen R&D Ireland (Janssen) and Johnson & Johnson (NYSE: JNJ) will provide a pre-recorded webcast for investors and other interested parties on Friday, May 3, at approximately 8:30 a.m., Eastern Time, to discuss simeprevir phase 3 clinical data presented at The International Liver Congress of the European Association for the Study of the Liver (EASL).
Millennium HealthCare Inc. (OTC Pink: MHCC) today announced that its Medical Device subsidiary signed an agreement with Atossa Genetics Inc. (NASDAQ: ATOS) for the distribution of Atossa's ForeCYTE Breast Health devices, which consist of the patented MASCT pump and ForeCYTE patient collection kits.
mPhase Technologies, Inc. (OTCBB: XDSL) reported today that it has received an Issue Notification from the U.S. Patent & Trademark Office for a key patent relating to a device for fluid spreading and transport.
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PLC Systems Inc. (OTCQB: PLCSF), a company focused on innovative medical device technologies, today announced that it will participate in the Taglich Brothers 10th Annual Small Cap Equity Conference.
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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today reported results for the quarter ended March 31, 2013.
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes,today announced that it will release first quarter 2013 financial results on Thursday, May 9, 2013 after market close.