Dr. Fertrin on the FDA Approval of Avatrombopag in ITP

Kleber Y. Fertrin, MD, PhD
Published: Tuesday, Jul 02, 2019



Kleber Y. Fertrin, MD, PhD, assistant professor, University of Washington School of Medicine, Seattle Cancer Care Alliance, discusses the FDA approval of avatrombopag (Doptelet) in immune thrombocytopenia (ITP).

On July 1, 2019, the FDA approved a supplemental new drug application to expand the use of avatrombopag to include the treatment of adult patients with chronic ITP who have had an insufficient response to prior therapy. The approval of the oral thrombopoietin receptor agonist is largely based on findings from a phase III trial, which showed that avatrombopag led to a platelet count of >50,000 per µL after 8 days of therapy in the majority of patients with chronic ITP, and was also superior to placebo in sustaining platelet counts in the target range during a 6-month period.

The approval is a major breakthrough, says Fertrin, as it is the second therapy to be approved for patients with relapsed/refractory disease. Moreover, avatrombopag is well tolerated by patients in comparison to eltrombopag (Promacta), says Fertrin. As such, it may become the preferred therapy for patients with comorbidities. 
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Kleber Y. Fertrin, MD, PhD, assistant professor, University of Washington School of Medicine, Seattle Cancer Care Alliance, discusses the FDA approval of avatrombopag (Doptelet) in immune thrombocytopenia (ITP).

On July 1, 2019, the FDA approved a supplemental new drug application to expand the use of avatrombopag to include the treatment of adult patients with chronic ITP who have had an insufficient response to prior therapy. The approval of the oral thrombopoietin receptor agonist is largely based on findings from a phase III trial, which showed that avatrombopag led to a platelet count of >50,000 per µL after 8 days of therapy in the majority of patients with chronic ITP, and was also superior to placebo in sustaining platelet counts in the target range during a 6-month period.

The approval is a major breakthrough, says Fertrin, as it is the second therapy to be approved for patients with relapsed/refractory disease. Moreover, avatrombopag is well tolerated by patients in comparison to eltrombopag (Promacta), says Fertrin. As such, it may become the preferred therapy for patients with comorbidities. 



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