Ipsen (EPA:IPN) said today that the FDA approved a supplemental indication for its Somatuline depot (lanreotide) injection for the treatment of carcinoid syndrome.
“The new indication for Somatuline depot offers patients in the U.S. a valuable treatment option for debilitating carcinoid syndrome associated with neuroendocrine tumors.,” Ipsen’s VP of R&D and chief scientific officer, Dr. Alexandre Lebeaut, said in prepared remarks. “It also reaffirms Ipsen’s global commitment to helping to improve lives of patients with cancer.”
The drug is also approved for the improvement of progression-free survival in patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.
“This new indication for Somatuline depot gives doctors the only somatostatin analog approved by the FDA in adults for both improving progression-free survival in patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic GEP-NETs and for the treatment of carcinoid syndrome,” Cynthia Schwalm, EVP & president of Ipsen’s North American biz, added. “The additional approval also confirms Ipsen’s commitment to developing research-driven treatments intended to help provide patients battling cancer with new therapy options.”
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