Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Teva Receives FDA Approval For Synribo For Injection - Quick Facts

RELATED NEWS
Trade TEVA now with 

Teva Pharmaceutical Industries Ltd. (TEVA: Quote) 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.

Register
To receive FREE breaking news email alerts for Teva Pharmaceutical Industries Limited and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Stocks turned in another strong performance during trading on Tuesday, extending the upward trend seen over the past several sessions. The gains on the day once again lifted the tech-heavy Nasdaq to a new fourteen-year closing high. President Barack Obama revealed Monday that he is dispatching Attorney General Eric Holder to Ferguson, Missouri, amid ongoing violence in the St. Louis suburb. Obama said Holder will travel to Ferguson on Wednesday to meet with the FBI agents and Justice Department personnel conducting an investigation of the shooting death of Michael Brown. The job of humanitarians has become more dangerous than ever, and last year was the most dangerous on record for humanitarian workers, according to a report published on Tuesday, marking World Humanitarian Day. The year 2013 set a new record for violence against civilian aid operations, with 460 aid workers assaulted in 251 incidents. More than one third or 155 of the victims were killed, 171 we
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.