logo
Share SHARE
FONT-SIZE Plus   Neg

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

Editors Pick
AIG reported a plunge in second-quarter profit, hurt by a decline at its insurance business, debt-related losses and lower gains from the sale of investments. However, its earnings topped Street estimates, partly on contribution from aircraft leasing giant AerCap. AIG also announced a boost in dividend and said it would buyback an additional $5 billion stock. Automakers on Monday reported strong U.S. vehicle sales for the month of July, driven by continued demand for trucks and sport-utility vehicles amid an improving economy, lower gas prices and easy availability of credit. Detroit's Big Three - General Motors Co., Ford Motor Co. and FCA US, LLC - all reported vehicle sales above analyst expectations. British lender Lloyds Banking Group Plc. Friday reported higher profit in its first half, benefited by increased net interest income and margin as well as lower impairment. Looking ahead, the company lifted its net interest margin forecast.
comments powered by Disqus
Follow RTT