India clears Roche’s 7-minute cancer injection Tecentriq for patients, with Phase IV trial condition

New Delhi: The technical committee constituted for supervising clinical trials on new chemical entities has cleared Swiss drug major Roche to import and market cancer drug Atezolizumab injection (Tecentriq) through subcutaneous (SC) route-under the skin injection for Indian patients.

The decisions is expected to provide relief to patients in the contry as the new subcutaneous injections will cut treatment time to nearly seven minutes from the 30-60 minutes in the standard intravenous (IV) infusion, besides saving on costs.

The panel's permission has been given with a condition that the company would conduct a Phase IV clinical trial in India.


"Switching from intravenous (IV) to subcutaneous (SC) administration of Atezolizumab can potentially reduce costs due to decreased healthcare professional time and improved patient convenience," a government official told ET.

"Tecentriq may be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient's home," he added.

Atezolizumab is an immunotherapy called an immune checkpoint inhibitor, which blocks the immune system's natural brakes to help immune cells fight cancer.

The technical committee under the Director General of Health Services (DGHS) was formed in 2013 following the directions of the Supreme Court.

In a recent meeting, Roche presented the proposal for grant of permission to import and market the drug product Atezolizumab injection (Tecentriq®) 1875 mg/15 mL vial for subcutaneous administration for the following indications with the request of local Phase III clinical trial waiver and commitment to conduct a Phase IV trial in India.

Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. It is a monotherapy for the first line treatment of patients of metastatic NSCLC.

The committee noted the pharmacokinetic-pharmacodynamic or PK/PD results of Asian & non-Asian population from the global clinical study for the ethnic differences in the PK parameters in the study. The committee further noted that firm has received the USFDA approval for the SC route on 12.09.2024.

The committee also asked the company to submit Phase IV clinical trial protocol to CDSCO within three months of grant of marketing authorisation.