Lunan Pharmaceutical's First Generic Axitinib Tablets Approved in China for Advanced Renal Cell Carcinoma

Source: Medical & Pharmaceutical Insights

On May 25, Lunan Pharmaceutical issued a press release stating that Axitinib Tablets, developed by its subsidiary Shandong New Time Pharmaceutical Co., Ltd., have been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have failed prior treatment with one tyrosine kinase inhibitor or cytokine therapy. According to the press release, this product is the first in China to be approved under the new Class 4 category and is deemed to have passed the consistency evaluation.

Axitinib is a small-molecule tyrosine kinase inhibitor (TKI). The innovator product was developed by Pfizer (brand name: Inlyta) and was approved in China in 2015 for the second-line treatment of renal cell carcinoma. Studies have demonstrated that at therapeutic doses, axitinib inhibits tyrosine kinase receptors, including vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, and VEGFR-3. These receptors are associated with pathological angiogenesis, tumor growth, and cancer progression. By inhibiting VEGF-mediated endothelial cell proliferation and survival, axitinib exerts its antitumor therapeutic effect.

It is worth noting that multiple authoritative domestic and international guidelines for the diagnosis and treatment of renal cancer, including those issued by the National Comprehensive Cancer Network (NCCN), the European Association of Urology (EAU), and the Chinese Society of Clinical Oncology (CSCO), have recommended axitinib as: second-line treatment following the failure of first-line molecular targeted therapy for advanced clear cell renal cell carcinoma. Additionally, the two combination therapies of axitinib combined with the PD-1 inhibitor pembrolizumab, and axitinib combined with the PD-L1 inhibitor avelumab, have both been approved in the United States for the first-line treatment of advanced renal cell carcinoma.

Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for 90% of all cases. Patients with early-stage RCC are typically asymptomatic; however, more than 30% of cases have already metastasized at the time of diagnosis. The 5-year survival rate for patients with metastatic disease is only 12%. As the disease progresses, symptoms may include hematuria, flank pain, weight loss, and anemia, among others. Currently, multiple treatment options are available for RCC patients, including surgery, targeted therapy, and immunotherapy.

According to the official NMPA website, previously only Pfizer's axitinib had been approved for marketing in China. The recent approval of Lunan Pharmaceutical's axitinib tablets marks the first generic version of this product, which will provide more treatment options for patients with advanced renal cell carcinoma.

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