Eltrombopag Granted FDA Approval for Severe Aplastic Anemia

Article

he FDA has expanded the approval of eltrombopag (Promacta) in combination with standard immunosuppressive therapy (IST) to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia.

The FDA has expanded the approval of eltrombopag (Promacta) in combination with standard immunosuppressive therapy (IST) to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia (SAA), according to Novartis, the manufacturer of eltrombopag.1 The agency also granted the agent a breakthrough therapy designation as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome (H-ARS).

The approval is based on a Novartis analysis sponsored by the National Heart, Lung, and Blood Institute (NHLBI) Division of Intramural Research Program and conducted under a Cooperative Research and Development Agreement. Findings showed that treatment with eltrombopag given concurrently with standard IST led to an overall response rate (ORR) of 79% (95% CI, 69%-87%) and a 44% complete response (CR) rate in patients with definitive IST-naïve SAA, both at 6 months. This compares with a 27% CR rate historically observed with standard IST alone.

"Patients with SAA sometimes do not respond to the current treatment standard of IST," said Phillip Scheinberg, MD, head, Division of Hematology, Hospital A Beneficência Portuguesa de São Paulo in Brazil, and previously with the NHLBI. "With this approval, physicians now have an option to add Promacta to the standard IST in a regimen that has demonstrated significant overall and complete response rates upfront in SAA and reduce the numbers of those who are unresponsive to initial therapy."

The full article can be viewed at OncLive.com.

Related Videos
Female Pharmacist Holding Tablet PC - Image credit: Tyler Olson | stock.adobe.com
African American male pharmacist using digital tablet during inventory in pharmacy - Image credit: sofiko14 | stock.adobe.com
Young woman using smart phone,Social media concept. - Image credit: Urupong | stock.adobe.com
selling mental health medication to man at pharmacy | Image Credit: Syda Productions - stock.adobe.com
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk - stock.adobe.com
Concept of health care, pharmaceutical business, drug prices, pharmacy, medicine and economics | Image Credit: Oleg - stock.adobe.com
Image credit: rawpixel.com | stock.adobe.com
Medical team -- Image credit: Flamingo Images | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.