logo
Share SHARE
FONT-SIZE Plus   Neg

Teva Receives FDA Approval For Synribo For Injection - Quick Facts

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Software giant Microsoft Corp. said Monday after the markets closed that its second quarter profit fell 11% from last year, hurt mainly by integration and restructuring costs as well as higher income tax expenses even as revenue increased 8% due to strong sales of its gadgets and cloud-based products. English-made Cadbury chocolates will no longer be available in the United States, the result of a settlement between Hershey and a New Jersey-based import company. Beloved treats such as the Cadbury Creme Egg will only be sold in the U.S. using American chocolate, angering those who say the creamier... Gas prices are set to climb again after a long time due to rising wholesale prices. According to Lundberg Survey, while the national average price of gas fell 13 cents in the past two weeks to $2.07 a gallon, it could soon rise due to increased costs of crude oil in the past 10 days.
comments powered by Disqus
Follow RTT