The Subject Expert Committee (SEC) on Oncology has declined Roche Products (India) Private Limited's request for a waiver of local Phase III and Phase IV clinical trials for Glofitamab and has instead recommended that the company conduct Phase III clinical trials in India before the drug can be considered for marketing approval.
The recommendation was made during the 17th SEC (Oncology) meeting held on 24 June 2026 at the CDSCO Headquarters in New Delhi.
Roche had sought permission to import and market Glofitamab concentrate for solution for infusion in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials (1 mg/mL).
The company proposed approval for two indications:
Glofitamab in combination with gemcitabine and oxaliplatin for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not eligible for autologous stem cell transplant (ASCT).
Glofitamab monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy.
During the review, the committee noted that Glofitamab has already received regulatory approvals in several major international markets, including the United States, United Kingdom, Japan, Australia, Canada, and the European Union, based on data from global clinical trials. However, India was not a participating country in those studies.
The SEC further observed that the company had not established that the proposed therapy offers a significant therapeutic advancement over currently available treatment options in India.
After detailed deliberations, the committee decided not to grant a waiver for local Phase III and Phase IV clinical trials for either of the proposed indications.
Instead, the committee recommended that Roche submit a Phase III clinical trial protocol to CDSCO covering both proposed indications before the application can proceed further.
The recommendation underscores CDSCO's continued emphasis on generating India-specific clinical evidence for oncology products when global trial data alone is considered insufficient to support marketing approval.
