Roche India asked to submit atezolizumab data for two cancer indications by CDSCO panel

India's Central Drugs Standard Control Organization's (CDSCO) oncology/hematology Subject Expert Committee, which advises the drug regulator, has asked the local subsidiary of Swiss pharma giant Roche (ROG SIX) to submit the efficacy results of its Phase III trial on Tecentriq (atezolizumab), an anti-cancer drug.

The committee has recommended that Roche submit data of Phase III study IMpassion131, already reported to regulatory authorities in the European Union, UK, Japan, and Switzerland. As part of the CDSCO's SEC request, IMpassion131, Indian patients subset and real-world data are also to be submitted.

The CDSCO's panel had previously in March recommended to the drug regulator to withdraw the approval it had given Roche India to market atezolizumab until safety and efficacy data on the Indian population was available.

Last month, the SEC committee recommended there is no objection for change in indication of Tecentriq in locally advanced or metastatic urothelial carcinoma indication, in line with the USFDA approvals.

Roche said the decision by the SEC "comes as a big hope for Indian patients and healthcare professionals as it enables them to continue having an immunotherapy option to treat/ manage mUC."