FDA grants a priority review of the new drug application for telotristat etiprate
On May 31, 2016, the U.S. Food and Drug Administration (FDA) granted a priority review of the new drug application for telotristat etiprate (Lexicon), and oral drug used to treat carcinoid syndrome. As the priority review status shortens the review process to 6 months from the standard 10 months, the FDA will decide whether to approve telotristat etiprate for commercial use by November 30, 2016.
“The granting of priority review by the FDA underscores the need for improving the lives of the patients and caregivers who live with carcinoid syndrome on a daily basis,” said Lexicon CEO Lonnel Coats.
Pancreas Journal Publishes Abstracts from the 2015 NANETS Annual Symposium
The 2015 NANETS Annual Symposium Abstracts are now in print in Pancreas 2016 Volume 45 #3, March issue. The abstracts can be viewed at no charge on the Journal's website.
FDA approves new indication for Novartis drug Afinitor® for progressive, non-functional GI and lung neuroendocrine tumors (NETs)
On February 26, 2016, the U.S. Food and Drug Administration (FDA) approved everolimus (Afinitor®, Novartis) tablets for the treatment of adult patients with progressive, well-differentiated, non-functional neuroendocrine tumors (NETs) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Afinitor received a priority review designation providing a shortened review period for drugs that treat serious conditions and offer a significant improvement in safety or effectiveness.