China NMPA approves KeChow’s tunlametinib for melanoma
19 Mar 2024
Phase 2Drug ApprovalImmunotherapyPriority ReviewCell Therapy
Preview
Source: Pharmaceutical Technology
In a Phase II trial in melanoma patients, tunlametinib demonstrated an overall response rate of 35.8%. Credit: Africa Studio / Shutterstock.com.
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.
See Also:
BMS’ cell therapy Abecma gains EC approval for multiple myeloma
Preview
Source: Pharmaceutical Technology
Metastatic Uveal Melanoma drugs in development, 2023
Preview
Source: Pharmaceutical Technology
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%.
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.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Drugs
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.