Sutent OKed as pancreatic NET treatment
NEW YORK — The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.
Pfizer announced Friday the approval of Sutent (sunitinib malate) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with locally advanced disease that can’t be removed through surgery. Pancreatic NET is a rare cancer reported in 2 million to 4 million people worldwide every year.
“We are delighted that Sutent has been granted approval by the FDA as an effective treatment option for individuals with pancreatic NET,” said Mace Rothenberg, SVP clinical development and medical affairs for Pfizer’s oncology business unit. This approval represents the third disease indication for Sutent, which was approved by the FDA in 2006 for treatment of patients with advanced kidney cancer and imatinib-resistant or intolerant gastrointestinal stromal tumor.
Imatinib is the generic name for Novartis’ drug Gleevec.
No comments found
Mylan receives FDA approval for generic Depakote Sprinkle capsules
PITTSBURGH — The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.
Mylan said Monday that the FDA had approved its divalproex sodium capsules in the 125-mg strength. The drug is a generic version of Abbott’s Depakote Sprinkle capsules and is used to treat certain types of epileptic seizures.
Divalproex sodium capsules had sales of about $89 million during the 12-month period ended in March, according to IMS Health.
No comments found
FDA approves Incivek as hepatitis C treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.
The FDA approved Incivek (telaprevir) to treat adults with chronic hepatitis C infection, particularly those who either have not received interferon-based drug therapy or who have not responded to prior therapies. The drug is approved for use with therapies that include ribavirin and peginterferon alfa.
“With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” FDA Office of Antimicrobial Products director Edward Cox said. “The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection.”
The announcement comes a little more than a week after the FDA approved Merck’s hepatitis C drug Victrelis (boceprevir).
if and when approved what type is it for as i have 3a