FDA seeks more data from Teva Pharm on Treanda

TEL AVIV Tue Oct 23, 2012 10:37am EDT

Related Topics

TEL AVIV Oct 23 (Reuters) - The U.S. Food and Drug Administration is seeking more data from Teva Pharmaceutical Industries regarding its request to expand the use of its chemotherapy drug Treanda for non-Hodgkin lymphoma.

Teva obtained Treanda through its acquisition of Cephalon last year and the drug generated $139 million in sales in the second quarter of 2012.

Teva is seeking to expand the use of Treanda as a first-line treatment of patients with indolent B cell non-Hodgkin lymphoma in combination with rituximab, an antibody used to treat non-Hodgkin lymphoma. The FDA requested additional data regarding progression free survival.

"Teva is currently evaluating all options to obtain the requested data," the company said in a statement on Tuesday.

Treanda is currently indicated as a secondary treatment for non-Hodgkin lymphoma. (Reporting by Tova Cohen)

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.