China’s NMPA grants conditional approval for AstraZeneca’s Calquence
2023-03-24
临床2期上市批准临床结果AACR会议
Preview
来源: Pharmaceutical Technology
AstraZeneca’s Calquence has been approved for the treatment of mantle cell lymphoma in adult patients. Credit: AstraZeneca.
China’s National Medical Products Administration (NMPA) has granted conditional approval for AstraZeneca’s Calquence (acalabrutinib) to treat mantle cell lymphoma (MCL) in adult patients who have previously received a minimum of one therapy.
The regulatory approval marks the first approved indication for Calquence in the country.
It is a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitorBruton’s tyrosine kinase (BTK) inhibitor which binds covalently to BTK, and then inhibits its activity.
It has already been approved to treat chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the US and Japan.
The BTK inhibitorBTK inhibitor has also received approval for CLL treatment in the EU and several other countries. It can be used in treatment-naïve patients as well as in relapsed or refractory settings.
AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “This approval for Calquence offers people living with mantle cell lymphoma in China an effective and tolerable new treatment option to help control their disease.
“As the first approval in China for Calquence, it is also an exciting step forward for AstraZeneca in blood cancers, enabling us to help more patients across the globe gain access to innovative treatments.”
The NMPA’s conditional approval was based on the data obtained from two clinical trials, including the international Phase II ACE-LY-004 trial and a Phase I/ II trial.
The single-arm, open-label Phase II trial was designed for assessing Calquence in relapsed or refractory MCL adult patients.
Findings showed that the participants treated with Calquence had an 80.6% investigator-assessed overall response rate (ORR), and that 39.5% of the patients achieved complete response (CR).
The open-label, multicentre Phase I/ II clinical trial was conducted in Chinese patients with relapsed or refractory MCL and other B-cell malignancies.
In the trial, patients treated with Calquence achieved an 82.4% ORR and a 35.3% CR, based on a blinded independent central review (BICR) analysis.
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
靶点
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。