SEC Refuses Local Clinical Trial Waiver For Roche’s Cancer Drug Tecentriq

New Delhi: The Subject Expert Committee (SEC) that advises the national drug regulator on approvals for drugs and clinical trials, among other matters, has refused a proposal from Roche Products (India) for approval of cancer drug Tecentriq through subcutaneous route with waiver of local clinical trial and asked the company to conduct phase III study for the proposed route.

The company submitted its proposal with the drug regulator for grant of permission to import and market atezolizumab injection (1875mg/15ml vial) branded as Tecentriq by new route of administration, that is subcutaneous route.

The request was to allow the import of the drug for indications of atezolizumab injection approved for intravenous (IV) route for sale or for distribution in India with local phase III and phase IV clinical trial waiver for under unmet need in the country.

The SEC (oncology) in a meeting held earlier this month, looked into the request of the company and observed that the formulation of atezolizumab is already available in the market. Besides, the Committee noted that the formulation and dose of proposed subcutaneous route is different from IV route and also India was not part of the global clinical study conducted to establish safety and efficacy data for the new route of administration.

“After detailed deliberation, the committee did not consider the firm’s request for approval of atezolizumab injection (1875mg/15ml) (Tecentriq) by proposed subcutaneous route of administration with waiver of local clinical trial,” said the Committee after the meeting.

The Committee recommended that the firm should conduct phase III study to establish safety and efficacy of the product for the proposed route.

The Swiss-drug major Roche on January 16, announced that it has received marketing authorisation for Tecentriq SC from the European Commission, making it European Union’s (EU) first PD-(L) cancer immunotherapy for subcutaneous (under the skin) injection. Tecentriq SC was first approved in Great Britain in August 2023 and the approved indications for Tecentriq SC mirror those of Tecentriq IV.

The subcutaneous drug combines the drug Tecentriq with Enhanze drug delivery technology from Halozyme Therapeutics. In addition to offering shorter treatment time, Tecentriq SC may be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient’s home, depending on national regulations and health systems. Roche is in discussion with several providers in Europe to include Tecentriq SC in cancer homecare initiatives where possible, it added.

The new subcutaneous injection will cut treatment time to approximately seven minutes, with most injections taking between four and eight minutes, claimed the company.

Tecentriq, as an IV, has been given directly into patients’ veins by IV infusion which takes approximately 30-60 minutes.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells.

The IV Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. The IV formulation was the first cancer immunotherapy approved for the treatment of a certain type of early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC).

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