AstraZeneca Gets CDSCO Panel Nod to Study anti-cancer drug Dato-DXd and Durvalumab

Written by Dr. Divya Colin Published On 2024-01-05T18:00:19+05:30 | Updated On 6 Jan 2024 5:15 PM GMT

AstraZeneca Gets CDSCO Panel Nod to Study anti-cancer drug Dato-DXd and Durvalumab

New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 3 clinical study to evaluate Dato-DXd and Durvalumab for neoadjuvant/adjuvant treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer.

This came after drug major AstraZeneca presented Phase III clinical trial protocol No. D926QC00001.

The above study is phase III randomised study to evaluate Dato-DXd and Durvalumab for neoadjuvant/adjuvant treatment of triple-negative or hormone receptor-low/HER2-negative Breast Cancer. This is a Phase III, 2-arm, randomised, open-label, a multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC (Triple negative breast cancer) or hormone receptor-low/HER2-negative breast cancer.

Datopotamab Deruxtecan (Dato-DXd), a Novel TROP2-directed Antibody–drug Conjugate, demonstrates potent antitumor activity by efficient drug delivery to tumor cells. The pharmacologic activity and mechanism of action of Dato-DXd were investigated in several human cancer cell lines and xenograft mouse models including patient-derived xenograft (PDX) models.

Durvalumab injection is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the growth of cancer cells.

Durvalumab is used alone to treat non-small cell lung cancer (NSCLC) that spreads to nearby tissues and cannot be removed by surgery but has not worsened after being treated with other chemotherapy medications and radiation treatments. It is also used in combination with tremelimumab-actl (Imjudo) and platinum-based chemotherapy to treat a certain type of NSCLC that has spread throughout the lungs and to other parts of the body.

Durvalumab injection is also used in combination with chemotherapy agents to treat extensive-stage small cell lung cancer (ES-SCLC) in adults whose cancer has spread throughout the lungs and to other parts of the body. It is also used in combination with chemotherapy agents to treat biliary tract cancer (BTC; cancer in the organs and ducts that make and store bile, the liquid made by the liver) in adults whose cancer has spread to nearby tissues or other parts of the body.

At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the Phase III clinical trial protocol No. D926QC00001.

After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as presented by the firm.

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Astra Zenecaastrazenecacdscodato-dxddurvalumabdatopotamab deruxtecanbreast canertriple-negative breast cancer

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.