AbbVie Announces China Approval of Venclexta® (Venetoclax) in Combination with Azacitidine for Adults with Newly Diagnosed AML Ineligible for Intensive Chemotherapy

Shanghai, December 8, 2020 /PRNewswire/ -- Global biopharmaceutical company AbbVie (AbbVie) announced today that Venclexta^®(Venetoclax Tablets) received conditional approval from the National Medical Products Administration on December 2, 2020, for use in combination with azacitidine for the treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy due to comorbidities, or who are aged 75 years or older. Venclexta^®(Venetoclax Tablets) is the first and currently only approved B-cell lymphoma-2 (BCL-2) inhibitor in China, marking the entry of the acute myeloid leukemia field in China into the era of targeted therapy.

Venclexta® -- The first and currently only approved B-cell lymphoma-2 (BCL-2) inhibitor in China

Acute Myeloid Leukemia: A Highly Aggressive and Refractory Hematologic Malignancy with Rapid Disease Progression and Extremely Low Patient Survival Rates^{[2], [3]}, the 5-year survival rate for diagnosed patients is only approximately 29%^[4]. The challenge is that not all patients can tolerate standard intensive chemotherapy to achieve complete remission (CR).^[5]. Therapeutic options for patients intolerant to intensive chemotherapy are very limited.^{[1], [2]}, with a median survival time of only 6–10 months^[6]。

Professor Wang Jianxiang, Deputy Director of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated, “Acute myeloid leukemia (AML) is an aggressive and difficult-to-treat disease that poses a serious threat to patients’ lives. As a clinician and an investigator in the clinical studies of venetoclax in China, I am delighted to see the approval of this drug. It breaks the decades-long stalemate in the AML treatment landscape, which has lacked breakthrough innovative therapies, and brings new hope to Chinese AML patients who are ineligible for intensive induction chemotherapy. Meanwhile, clinical studies have demonstrated that venetoclax significantly prolongs overall survival (OS) in patients. Therefore, I believe venetoclax is poised to become a standard-of-care treatment for this subset of AML patients.”

“Veklury”^®“Emerging in response to the times, its approval holds epoch-making significance: it marks AbbVie China’s entry into the field of oncology treatment. More importantly, it provides a novel targeted therapy option for newly diagnosed adult patients with acute myeloid leukemia (AML) in China who are ineligible for intensive induction chemotherapy due to comorbidities, or who are aged 75 years and older,” said Ou Silang, General Manager of AbbVie China. “In recent years, reforms to China’s drug review and approval system have continued to deepen, accelerating the availability of more global innovative medicines in China. Leveraging this favorable momentum, China has become one of the first countries to approve Venclexta.”^®...one of the pioneering countries. Chinese patients are also among the first to benefit from the new first-line treatment.”

This time, Weikela^®(Venetoclax Tablets) Approved in China, Supported by M14-358 Clinical Study Data. In the study, 84 patients with newly diagnosed acute myeloid leukemia received Venclexta^®Combined azacitidine therapy. Among them, 67 patients were aged 75 years or older, or had known comorbidities that precluded intensive induction chemotherapy. Study results showed that the median duration of response for patients achieving complete remission (CR) was 5.5 months (range: 0.4–30 months). Duration of response was defined as the time from the first recorded complete remission to the data cutoff date, or from complete remission to relapse. The median time to achieve first complete remission, or complete remission with partial hematologic recovery (CRh), was 1.0 month (range: 0.7 to 8.9 months).^[7]。

AbbVie – A Top-10 Global Research-Based Biopharmaceutical Company

February 2020, AbbVie^®The marketing application for (venetoclax tablets) has been granted priority review by the Center for Drug Evaluation of the National Medical Products Administration. In addition, Venclexta^®Included in the Hainan Free Trade Port Boao Lecheng Global Special Drug Insurance in August 2020.

Looking globally, only Venclexta^®Significant therapeutic advances have also been achieved in the field of acute myeloid leukemia (AML): the therapy has been approved in more than 20 markets, including the United States, and has received five Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA), two of which are for the treatment of acute myeloid leukemia.