TAIPEI (Taiwan News) — Taiwan’s PharmaEssentia announced Sunday that its drug Ropeg has been recommended in the US National Comprehensive Cancer Network (NCCN) treatment guidelines as a therapy for high-risk essential thrombocythemia, a rare blood disorder.
Essential thrombocythemia (ET) causes the body to produce too many platelets, increasing the risk of blood clots, heart attacks, and strokes, according to Cleveland Clinic. NCCN guidelines cover care for over 97% of people in the US affected by or at risk for cancer and are updated regularly to reflect the latest research and treatment advances, according to NCCN.
Ropeg (ropeginterferon alfa-2b) is now listed as a Category 1 first-line therapy. NCCN defines Category 1 as a treatment supported by strong clinical evidence and expert consensus, while first-line indicates it has clear advantages in efficacy and safety, making it a preferred option in clinical practice, according to CTEE.
The recommendation is based mainly on the Surpass-ET Phase III clinical trial, which found that 42.9% of patients treated with Ropeg achieved a long-lasting clinical response. By comparison, 6% of patients receiving the standard anagrelide treatment reached the same outcome, a difference considered highly significant.
Institutional investors view the recommendation as a key step toward Ropeg’s US ET market entry. They noted that the drug received high-level international guideline recognition even before US Food and Drug Administration approval.
The FDA has set Aug. 30 as the target date to complete its review of Ropeg for ET. If approved, it would become the first FDA-approved ET treatment in nearly 30 years.
Analysts say the expanded use of Ropeg across major rare blood cancers will further strengthen its global competitiveness. PharmaEssentia CEO Lin Ko-chung (林國鐘) called the recognition a “major milestone” for the company and the medical community.
Lin noted that Ropeg, branded as Besremi, is already the only FDA-approved drug listed by NCCN as a first-line therapy for polycythemia vera, a rare blood cancer. The ET designation is expected to accelerate insurance coverage for patients.
Following the announcement, PharmaEssentia’s stock reached its daily limit-up of 10% early in Monday’s session. It remained locked at NT$660 (US$21) until the close, according to Yahoo Stocks.
