The China National Medical Products Administration (NMPA) has approved KeChow Pharma’s tunlametinib (HL-085) for treating patients with neuroblastoma ras viral oncogene homolog (NRAS) mutated advanced melanoma.
Tunlametinib, a mitogen-activated protein kinase (MEK) inhibitor, becomes the first targeted therapy approved for this group of patients.
It is also the first product developed in-house by KeChow since its establishment.
The Center for Drug Evaluation of the NMPA had previously granted a priority review for the company’s new drug application for tunlametinib.
The decision for approval is based on the outcomes of a multicentre, single-arm Phase II registrational clinical trial in China involving 100 patients.
Tunlametinib’s clinical efficacy data demonstrated an overall response rate (ORR) of 35.8%, median progression-free survival of 4.2 months, and a disease control rate of 72.6%.
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Further subgroup analysis revealed that subjects who had previously undergone immunotherapy had an ORR of 40.6%.
Rash was the most frequently observed treatment-related skin event while the most common severe treatment-related adverse event was a rise in blood creatine phosphokinase.
Tunlametinib showed enhanced pharmacokinetic characteristics and greater target inhibition versus other licensed MEK inhibitors.
KeChow founder, CEO and chairman Dr Hongqi Tian stated: “Tunlametinib, approved in China, is the first internally designed and developed molecule by the KeChow team.
“The approval of tunlametinib is an important milestone to provide new treatment options for Chinese patients with NRAS-mutated advanced melanoma who previously received PD-1/PD-L1.
“We would like to express our sincere gratitude to the clinicians and patients who participated in our trials, and we thank the health authorities for their strong support. We are committed to making tunlametinib available in China as soon as possible to serve this patient population.”
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