AstraZeneca Submits New Indication Application for PD-L1 Inhibitor Durvalumab in China

Feb 21, 2025 13:48 CST Updated 13:48

AstraZeneca

Biopharmaceutical Manufacturer

Today (On February 21), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA),AstraZeneca（AstraZeneca）TheAnti-PD-L1 Monoclonal Antibody Durvalumab InjectionAnother new indication marketing application has been accepted, with the specific indication yet to be disclosed. Public data shows that DurvalumabPreviously approved in China for the treatment of non-small cell lung cancer, extensive-stage small cell lung cancer, and biliary tract cancer indications,In addition, the product has at least three new indications for marketing applications that have been accepted by the CDE and are currently in the review stage.

Screenshot source:CDE Official Website

Durvalumab (trade name: Imfinzi) is a humanized PD-L1 monoclonal antibody that can block the binding of PD-L1 to PD-1 and CD80, thereby blocking tumor immune escape and relieving the suppression of immune response.

In China, durvalumab was first approved by the NMPA in December 2019 for patients who did not experience disease progression after concurrent chemoradiotherapy based on platinum-containing drugs.Unresectable, Stage III Non-Small Cell Lung CancerPatient treatment; In July 2021, the drug was approved in combination with etoposide and platinum-based (carboplatin or cisplatin) chemotherapy regimens.For the first-line treatment of extensive-stage small cell lung cancer; In November 2023, durvalumab received NMPA approval for use in combination with gemcitabine and cisplatin for locally advanced or metastaticFirst-line Treatment for Adult Patients with Biliary Tract Cancer (BTC)。

Globally, durvalumab has been approved in many countries for the treatment of various types of lung cancer. Durvalumab isStage III Unresectable NSCLC with No Disease Progression After ChemoradiotherapyThe global standard of care for patients. Additionally, it has been approvedUnitedNeoadjuvant chemotherapy is used forPerioperative Treatment for Resectable NSCLC, and withImjudo (Tremelimumab) Short-Term Regimen Combined with Chemotherapy for the Treatment of Metastatic NSCLC。

For small cell lung cancer (SCLC),Durvalumab has beenApprovalUsed inAdult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after receiving platinum-based concurrent chemoradiotherapy (cCRT); Combined chemotherapy (etoposide and carboplatin or cisplatin) for extensive-stage SCLC.

In addition to the lung cancer indication, durvalumab has also been approved in multiple countries for the treatment of locally advanced or metastatic disease in combination with chemotherapy (gemcitabine plus cisplatin).Biliary Tract Cancer, combined with tremelimumab for the treatment of unresectableHepatocellular Carcinoma (HCC). In Japan and the EU, durvalumab has also been approved asMonotherapy for Unresectable Hepatocellular CarcinomaIn the United States, durvalumab has also been approved for use in combination with chemotherapy (carboplatin and paclitaxel), followed by durvalumab monotherapy.Primary Advanced or Recurrent Endometrial Cancer with Mismatch Repair Deficiency (dMMR). In the EU, durvalumab combined with chemotherapy followed by olaparib (Lynparza) and durvalumab isApprovalUsed forMismatch repair proficient (pMMR)Patients with advanced or recurrent endometrial cancer.

As part of a broad development program, durvalumab is being investigated as a monotherapy and in combination with other anticancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, various gastrointestinal and gynecological cancers, and other solid tumors.

For example, on February 15 this year, AstraZenecaAnnouncementDurvalumabPerioperative treatment regimen, used in combination with neoadjuvant chemotherapy, in patients with muscle-invasive bladder cancer (MIBC)In China, event-free survival (EFS) and overall survival (OS) were improved. Based on the results of this study, durvalumab is currently under review in the EU, Japan, and other countries and regions.

We look forward to more good news about this product, benefiting more patients.

References:

[1]Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Feb 21, 2025, fromhttps://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Imfinzi perioperative regimen improved event-free survival and overall survival across muscle-invasive bladder cancer patients regardless of complete pathology response status in post-hoc exploratory analysis of NIAGARA Phase III trial. Retrieved February 14, 2025, from https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-perioperative-regimen-improved-event-free-survival-and-overall-survival-of-niagara-phase-iii-trial.html

[3] Imfinzi® in combination with chemotherapy approved in China as the first immunotherapy regimen for patients with advanced biliary tract cancer.Retrieved Nov 14，2023, from https://mp.weixin.qq.com/s/ZuVw857_0AEuAiw9vn943g

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