NMPA Approves New Indication for Blood Cancer Drug Venclexta, Filling Treatment Gap for High-Risk Leukemia Patients

China Finance Online, July 3rd: Today, the National Medical Products Administration approved a new indication for the innovative hematology oncology drug Venclexta (Venetoclax Tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) with 17p deletion who have received at least one prior therapy.

This approval marks the official application of the world's first BCL-2 inhibitor in China for the precise targeted treatment of CLL, providing new hope for high-risk patients with relapsed or refractory leukemia who have long faced a lack of treatment options after disease progression, effectively filling the treatment gap in China's chronic lymphocytic leukemia field.

CLL/SLL is a chronic hematologic malignancy that predominantly affects middle-aged and elderly individuals. With the acceleration of aging in China, its incidence is on the rise. Among these patients, chromosome 17p deletion is a high-risk factor for the prognosis of relapsed or refractory CLL, and such patients typically show poor response to conventional therapies with extremely poor outcomes. Under current standard treatment options, the median survival period is less than five years.

The pathogenesis of CLL/SLL is related to the high expression of BCL-2, and Venetoclax precisely targets the BCL-2 for treatment. After the high expression of BCL-2, it inhibits the normal apoptosis of tumor cells, which is one of the more important factors in the pathogenesis of CLL.

Professor Li Jianyong, Director of the Lymphoma Center at Jiangsu Provincial People's Hospital, introduced that clinical studies have shown that Venetoclax can achieve a significant overall response rate and durable remission in CLL/SLL patients with 17p deletion who have received at least one prior therapy.

Dong Lijun, the relevant responsible person of AbbVie China, stated that the approval of the new indication for Venclexta not only redefines the industry standard for the treatment of CLL/SLL but also reshapes the treatment landscape for high-risk patients. "We will continue to collaborate with various parties to further improve drug accessibility while continuously exploring innovative cancer therapies, allowing more Chinese patients to benefit from precision medicine."

Data shows that as the world's first approved BCL-2 inhibitor, Venetoclax has accumulated extensive real-world treatment experience in international clinical practice over the past decade. In 2020, it was approved through China's expedited review and approval channel as a clinically urgently needed medication for the treatment of Acute Myeloid Leukemia (AML). The recently approved indication for Chronic Lymphocytic Leukemia (CLL) marks its second approved indication in China.