On September 11, 2019, Chia Tai Tianqing obtained the drug registration
approval for Anlotinib Hydrochloride Capsules for the treatment of small-cell
lung cancer (SCLC). The product, as a monotherapy, is indicated for patients
with progressive or recurrent SCLC who have previously received at least two
lines of chemotherapy. This marks the third approved indication for anlotinib,
following advanced non-small-cell lung cancer (NSCLC) and soft tissue sarcoma.
The approval of this new indication designates anlotinib as the first targeted
therapy for SCLC in China. It pioneers targeted treatment regimens for SCLC
domestically, bringing a novel therapeutic option to SCLC patients and improving
their quality of life.
Lung cancer is a malignant tumor with high morbidity and mortality rates worldwide. In recent years, the incidence and mortality of lung cancer in China have been rising rapidly. SCLC is difficult to detect in its early stages and is usually diagnosed only when it has metastasized to other parts of the body. Characterized by high invasiveness and poor prognosis, SCLC has a 5-year survival rate of less than 5%, and the median overall survival of untreated patients is merely 2 to 4 months. Since lobaplatin was approved for marketing in 2005 for the treatment of SCLC in combination with etoposide, no new drugs have been approved for this indication in China over the past 15 years, leaving an urgent unmet medical need for new therapeutic agents among SCLC patients.
Anlotinib Hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor (TKI) that exerts dual effects of anti-tumor angiogenesis and tumor growth inhibition. Clinical trial data demonstrated that compared with the placebo group, patients with SCLC treated with Anlotinib Hydrochloride Capsules achieved significant prolongation in overall survival (OS) and progression-free survival (PFS). The product has a low incidence of adverse reactions, with mild severity, and the vast majority of these events are manageable.
The clinical trial results of anlotinib were first presented as an oral report at the 2018 World Conference on Lung Cancer (WCLC). Based on its outstanding performance in clinical studies, anlotinib has been recommended as a Category Ⅱ option for the third-line and beyond treatment of SCLC in the 2019 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Primary Lung Cancer.
As the first small-molecule multi-targeted receptor tyrosine kinase inhibitor approved in China for the later-line treatment of SCLC, anlotinib has broken the deadlock of having no available drugs for advanced SCLC treatment. It provides clinicians with more therapeutic options, benefits more SCLC patients, and thus holds positive social significance and broad application prospects.
