AstraZeneca gets CDSCO panel nod to study anticancer drug Durvalumab

Published On 2022-06-03 13:30 GMT | Update On 2022-06-03 13:30 GMT

New Delhi: Pharmaceutical major, AstraZeneca has got the go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of anti-cancer drug Durvalumab.However, the approval is subjected to conditions that the study Principal Investigator (Medical Oncologist) and his team should have Radiotherapy expert...

New Delhi: Pharmaceutical major, AstraZeneca has got the go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of anti-cancer drug Durvalumab.

However, the approval is subjected to conditions that the study Principal Investigator (Medical Oncologist) and his team should have Radiotherapy expert as co-investigator or subinvestigator at each site.

Furthermore, The committee also suggested that randomization stratification should be worked out for those subjects included in the trial, who medically have resectable oesophageal squamous cell carcinoma (ESCC), however refused surgery (inclusion criteria 5).

This came after the firm presented the proposed Phase III trial protocol no. D910SC000001, Ver:2.0 dated 16Nov2021 (KUNLUN) before the committee.

Durvalumab is an Anti-PD-L1 monoclonal antibody. Durvalumab is used to treat urothelial cancers that are locally advanced or metastatic in patients who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Durvalumab is used for patients with unresectable stage III non-small-cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

At the recent SEC meeting for Oncology and Haematology held on 26th May 2022, the expert panel reviewed the proposal to conduct the phase III clinical trial of the anti-neoplastic drug Durvalumab.

After detailed deliberation, the committee recommended for grant of permission to conduct the clinical trial with the condition that:

1)The study Principal Investigator (Medical Oncologist) and his team should have a Radiotherapy expert as a co-investigator or sub-investigator at each site.

2) The committee also suggested that randomization stratification should be worked out for those subjects included in the trial, who medically have resectable oesophageal squamous cell carcinoma (ESCC), however, refused surgery (inclusion criteria 5).

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Dr. Divya Colin

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.

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AstraZeneca gets CDSCO panel nod to study anticancer drug Durvalumab

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