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

Quick Facts

Editors Pick
Uber has developed new software that will track and inform drivers of the ride-hailing app about things like sudden acceleration, harsh braking or whether they are holding their phones while driving. The software is part of an updated version of Uber's app for drivers. One third of its PlayStation Plus users pay for games, Sony revealed on Wednesday. Wal-Mart Stores Inc. is offering a free 30-day trial of its ShippingPass subscription program. In order to better compete with Amazon.com (AMZN), Wal-Mart has introduced the $49-a-year ShippingPass subscription service last year, which gives a user unlimited two-day shipping.
comments powered by Disqus
Follow RTT