CDSCO panel nod to Roche anti cancer drug Atezolizumab for metastatic triple negative breast cancer
New Delhi: Based on the justification provided by the pharmaceutical giant Roche, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has approved Roche's anticancer drug Atezolizumab for continuation of indication of metastatic triple negative breast cancer.
Atezolizumab is a humanized monoclonal antibody used to prevent the interaction of PD-L1 and PD-1, removing inhibition of immune responses seen in some cancers. This medication is reserved for patients whose tumors express PD-L1, cannot receive platinum based chemotherapy, or whose tumors do not respond to platinum based chemotherapy.
This drug helps the person's immune system to fight against the cancer cells, and helps to slow tumor growth.The drug is indicated mainly for Locally Advanced or Metastatic Urothelial Carcinoma,Non-Small Cell Lung Cancer,Extensive-Stage Small Cell Lung Cancer,Unresectable or Metastatic Hepatocellular Carcinoma,and Unresectable or Metastatic Melanoma.
In addition, the committee asked the firm to present the documentary evidence for submission of data of Phase III study IMpassion131 already reported to regulatory authorities such as EU,UK, Japan, and Switzerland and the efficacy results with current status of the Phase III study IMpassion130,Indian patients subsets along with real world data.
In connection with the above, at recent SEC meeting for Oncology and Hematology, the drug maker Roche presented the additional data of Atezolizumab for continuation of indication of metastatic triple negative breast cancer.
At the recent SEC meeting for Oncology and Hematology held on 23.06.2022, the expert panel reviewed the additional data of anti cancer drug Atezolizumab for the continuation of indication of metastatic triple negative breast cancer presented by drug maker Roche.
After detailed deliberation the committee recommended for approval of the said indication inline with EMA approval namely "Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease".
