logo
Plus   Neg
Share
Email
Comment

Teva Receives FDA Approval For Synribo For Injection - Quick Facts

Teva Pharmaceutical Industries Ltd. (TEVA) announced Friday that the U.S. Food and Drug Administration or FDA approved Synribo (omacetaxine mepesuccinate) for Injection to treat adult patients with chronic phase or CP or accelerated phase or AP chronic myeloid leukemia or CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors or TKIs.

The indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Synribo. It will be available for prescribing shortly.

The company said that the approval is based on an analysis of combined data subsets from two Phase II, open-label, multicenter studies. The pooled analysis included patients who had received 2 or more approved TKIs and, at a minimum, had evidence of resistance or intolerance to dasatinib and/or nilotinib. 47% of CP patients and 63% of AP patients had failed treatment with imatinib, dasatinib, and nilotinib. The majority of patients had also received other treatments including hydroxyurea, interferon, and cytarabine.

synribo will be dosed twice daily for 14 consecutive days of a 28-day cycle at treatment induction, and twice daily for seven consecutive days of a 28-day cycle during maintenance therapy once a response is achieved.

Serious adverse reactions, including myelosuppression, bleeding, and hyperglycemia, have been associated with Synribo. Some reactions, such as myelosuppression and cerebral hemorrhage, have been fatal. Women should be advised to avoid becoming pregnant while using Synribo.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
BlackRock Inc., the world's largest asset manager, said it plans to speak with gun makers and distributors following public outcry after the Florida high school shooting that killed 17 people. BlackRock, which had $6.3 trillion in assets under management as of December 31, 2017, holds shares in gun makers Sturm Ruger & Co. Inc. as well as American Outdoor Brands Corp. An upgraded boarding in Southwest Airline will cost you more. The airline usually not assign seats to passengers, but one can choose from an open seat. The Upgraded Boarding will allow passengers to choose from A1 - A15 boarding positions. The cost for these positions would be $30, $40 and $50, depending on flight and route. This option can be availed from the ticket counter or gate. Citigroup Inc.'s co-head of mergers and acquisitions, Peter Tague, is leaving the company, according to media reports, citing people familiar with the matter. Tague has been co-head of Global M&A business at Citigroup since March 2012, alongside Cary Kochman and Mark Shafir. It was not immediately clear what Tague intends to do after he leaves Citigroup.
comments powered by Disqus
Follow RTT