Novartis' Ceritinib Approved in China for First-Line Treatment of ALK-Positive NSCLC

Source: Jike Pharmaceutical News

On May 28, Novartis Oncology (China) announced that the National Medical Products Administration (NMPA) of China had approved ceritinib capsules (brand name: Zykadia®), an oral small-molecule ALK inhibitor from Novartis, as monotherapy for patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). With this approval, ceritinib gains a new indication, entering the first-line treatment landscape for patients with ALK-positive locally advanced or metastatic NSCLC, thereby providing physicians with a new therapeutic option and delivering tangible benefits to patients.

The approval of this indication is based on the ASCEND series of studies, among which the results from ASCEND-4 and ASCEND-8 established the role of ceritinib as a first-line treatment for ALK-positive advanced non-small cell lung cancer (NSCLC) in China. In the earlier ASCEND-4 clinical study, ceritinib was administered at a dose of 750 mg under fasting conditions, achieving a median progression-free survival (PFS) of 16.6 months in the overall first-line population and 26.3 months in the Asian subgroup.

In the ASCEND-8 clinical study, the efficacy of ceritinib 450 mg administered with food was significantly improved. Currently, the longest follow-up period has exceeded 25 months, and the median progression-free survival (PFS) has not yet been reached. Meanwhile, the objective response rate (ORR) for the 450 mg dose taken with food reached 78%. At the 450 mg dose with food, the safety profile and treatment adherence of the drug were markedly enhanced, with the relative dose intensity increasing from 83.7% to 100%. Additionally, the pharmacoeconomic value of the drug was substantially improved. It is believed that the approval of ceritinib at the 450 mg dose with food for broader indications will provide physicians with a new therapeutic option for lung cancer, bringing greater hope and benefits to patients.

In recent years, lung cancer has ranked first among all malignant tumors in China in terms of both incidence and mortality. More than 85% of lung cancer cases are non-small cell lung cancer (NSCLC)¹, with ALK-positive patients accounting for 3%–7% of NSCLC cases. This subtype is more common among young, non-smoking Asians and is mostly diagnosed at an advanced stage. However, ALK rearrangement is a significant driver gene, and patients harboring ALK rearrangements can benefit from treatment with tyrosine kinase inhibitors (TKIs) targeting ALK kinase. As the first second-generation ALK inhibitor introduced in China, ceritinib was initially approved for the treatment of ALK-positive locally advanced or metastatic NSCLC in patients who had progressed on or were intolerant to prior crizotinib therapy.

About Ceritinib

Ceritinib was approved for marketing in mainland China in May 2018, providing a safe and effective treatment with significant clinical benefits for patients with ALK-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. In October of the same year, it was included in the National Reimbursement Drug List. In May 2019, the China Women's Development Foundation initiated and launched the "Novartis Love Patient Assistance – Zykadia Charitable Assistance Program" to help lung cancer patients continue to receive standardized treatment, alleviate the financial burden during treatment, and assist more patients in improving their survival and quality of life. The program features donated medications provided free of charge by Novartis AG.

Ceritinib has been approved for marketing in multiple countries and regions worldwide, including the United States, the European Union, Canada, and Japan. Meanwhile, Novartis’s oncology pipeline, particularly in lung cancer, continues to strengthen, featuring agents such as the BRAF inhibitor dabrafenib, the MEK inhibitor trametinib, the c-MET inhibitor capmatinib (INC280), and the IL-1β inhibitor canakinumab (ACZ885). Multiple clinical trials are currently being conducted in mainland China, encompassing diverse mechanisms of action and covering various disease subtypes. These efforts are poised to deliver comprehensive benefits to patients in the near future.

References:

[1] Zykadia® (ceritinib capsules) approved for a new indication: for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC). Retrieved 2020-05-28, from https://mp.weixin.qq.com/s/f0-B0DTdD09Vrjaw6Y9RFQ

(Original Title: Congratulations! Novartis’ Ceritinib Approved in China for First-Line Treatment of ALK-Positive Non-Small Cell Lung Cancer (NSCLC))

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