Merck has received China’s National Medical Products Administration (NMPA) approval for Welireg (belzutifan) to treat tumours associated with Hippel-Lindau (VHL) disease.
Welireg is an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor.
It is indicated for adults with VHLisease who need treatment for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumours (pNET).
The US drugmaker said that Welireg is the first and only approved HIF-2α inhibitor in China.
Welireg is also approved in the US for the treatment of adult patients with advanced RCC after treatment with a PD-1 or PD-L1 inhibitor and a VEGF-TKI inhibitor.
Merck Research Laboratories senior vice president and oncology, global clinical development head Marjorie Green said: “This approval of WELIREG brings the first and only systemic therapy to adult patients in China with certain VHL disease-associated tumours.
“We are committed to bringing innovative treatment options to patients in need around the world and are proud to offer eligible adult patients in China a first-in-class HIF-2α inhibitor as a possible treatment option.”
The NMPA approval of Welireg is based on positive objective response rate (ORR) and median duration of response (DOR) results from the Phase 2 LITESPARK-004 trial.
The Phase 2 study evaluated Welireg in 61 patients with VHL-associated RCC.
In the study, Welireg showed 49% ORR in patients with VHL-associated RCC, and 63% ORR in patients with VHL-associated CNS hemangioblastomas.
Also, the drug showed an ORR of 83% in patients with VHL-associated pNET.
Furthermore, Merck is evaluating Welireg in advanced RCC and other tumour types through a clinical development programme, as monotherapy and together with other medicines.
