Roche India Atezolizumab marketing approval to be revoked for two indications: CDSCO panel
New Delhi: In a major setback to Roche Products (India), the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended that pharma major Roche's anticancer drug Atezolizumab's marketing approval be revoked for the indications of triple negative breast cancer (TNBC) and urothelial carcinoma until safety and efficacy data on the Indian population is available.
This came in the wake of the proposal presented by the drug maker Roche India at latest SEC meeting for oncology and haematology, dated 24.02.2022.
Earlier, at 117th SEC meeting for oncology and haematology held on 27.01.2022, the firm informed the expert panel regarding the voluntary withdrawal of triple negative breast cancer and metastatic urothelial carcinoma indications for Atezolizumab injection in USA.
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.
At recent SEC meeting, the committee noted that the firm was granted accelerated approval by US FDA subject to the condition that continued approval for the indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Further, the drug did not meet the primary endpoints in the Phase III confirmatory trial.
The committee further noted that the initial approval for Atezolizumab was accorded in March 2017 based on the Phase II data generated in USA (accelerated approval).
"However, the indication has been voluntarily withdrawn in consultation with US FDA as the Phase III study IMvigor211 did not meet the primary end-point." the committee minutes added.
After detailed deliberation, the committee recommended that the firm should submit safety and efficacy data from Phase III clinical trial in Indian Population along with the safety and efficacy results of the Indian sub-set in the global clinical trial carried out in the country for continued marketing of the drug in the Urotherlial carcinoma and triple negative breast cancer (TNBC).
The committee further recommended that the approval for marketing for the indication in the country for Urotherlial carcinoma and triple negative breast cancer (TNBC) should be withdrawn till such time safety and efficacy data are available in Indian population.
