India approves Roche’s faster, cost-saving 7-minute cancer therapy Tecentriq SC: Report

Atezolizumab is used for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously undergone chemotherapy, and as a first-line monotherapy for metastatic NSCLC

India’s drug regulatory panel has cleared Swiss pharma giant Roche to introduce a faster, more convenient form of its cancer drug Atezolizumab (Tecentriq) for local patients, an Economic Times report said on Tuesday.

Already USFDA-approved, under-the-skin jab can be administered in just seven minutes to the patient. This is dramatic cut from the 30–60 minutes required for the current intravenous infusion, and is expected to lower treatment costs while improving patient comfort, the ET report added.

This approval, as per ET, is expected to significantly benefit cancer patients in the country, as the SC formulation can be administered in about seven minutes, compared to the 30–60 minutes typically required for the intravenous (IV) infusion. The shift is also anticipated to bring down treatment costs.

The committee’s clearance comes with the condition that Roche will 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 The Economic Times. The official added that Tecentriq could be administered outside hospital settings — such as in community care facilities or even at a patient’s home — by a qualified healthcare professional.

The ET report describes Atezolizumab as an immune checkpoint inhibitor. This means that it is a type of immunotherapy that works by releasing the immune system’s natural brakes, enabling immune cells to better target and attack cancer cells.

The technical committee, which operates under the Director General of Health Services (DGHS) and was formed in 2013 following a Supreme Court directive, recently reviewed Roche’s application. The company sought permission to import and market Atezolizumab injection (Tecentriq®) 1875 mg/15 mL vial for SC administration in specific cancer indications, while requesting a waiver for local Phase III clinical trials and committing to Phase IV studies in India.

As per ET, Atezolizumab is used for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously undergone chemotherapy, and as a first-line monotherapy for metastatic NSCLC. The committee evaluated pharmacokinetic and pharmacodynamic (PK/PD) data from both Asian and non-Asian populations in global clinical studies, noting there were no significant ethnic differences in PK parameters.

The Economic Times also reported that Roche has already received USFDA approval for the SC formulation on September 12, 2024. The committee directed the company to submit its Phase IV clinical trial protocol to the Central Drugs Standard Control Organisation (CDSCO) within three months of receiving marketing authorisation in India.