NMPA (China) approves HL 085 (tunlametinib) to treat neuroblastoma ras viral oncogene homolog (NRAS) mutated advanced melanoma.-Shanghai KeChow Pharma,.
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 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%. Further subgroup analysis revealed that subjects who had previously undergone immunotherapy had an ORR of 40.6%. ash 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.
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