Handok wins Korean approval for Vonjo in myelofibrosis with severe thrombocytopenia

The Ministry of Food and Drug Safety (MFDS) said Thursday it has approved Handok’s Vonjo Capsule (pacritinib citrate) for myelofibrosis, providing a new treatment option for patients with severe thrombocytopenia.

Myelofibrosis is a type of myeloproliferative neoplasm in which progressive scarring of the bone marrow disrupts its ability to produce blood cells normally.

The headquarters of the Ministry of Food and Drug Safety in Osong, North Chungcheong Province (KBR photo)

Vonjo is indicated for adults with primary myelofibrosis or secondary myelofibrosis following polycythemia vera or essential thrombocythemia.

The MFDS said Vonjo is expected to help patients with limited treatment options, particularly those with intermediate- or high-risk myelofibrosis and platelet counts below 50 × 10⁹/L.

The regulator previously designated Vonjo as the 32nd product under its Global Innovative Products on Fast Track (GIFT) program and conducted an expedited review to facilitate its early introduction into clinical practice and improve patient access.

“We will continue to leverage our regulatory science expertise to swiftly review and approve treatments whose safety and efficacy have been sufficiently demonstrated, helping expand treatment opportunities for patients,” the MFDS said.