Roche India gets CDSCO panel nod to manufacture, market anticancer drug Entrectinib capsules

This approval is subject to condition that the firm should conduct Phase IV clinical trial in the country in 50 patients for which the protocol should be submitted to CDSCO within two months of approval of the drug for review by the committee.

This came in line with the proposal presented by the drug maker, Roche Products for manufacturing & marketing Entrectinib capsules 100mg and 200mg along with the justification of a local clinical trial waiver before the committee.

Entrectinib is an anti-cancer medication used to treat ROS1-positive non-small cell lung cancer and NTRK fusion-positive solid tumors. It is a selective tyrosine kinase inhibitor (TKI), of the tropomyosin receptor kinases (TRK) A, B, and C, C-ros oncogene 1 (ROS1), and anaplastic lymphoma kinase (ALK).

Entrectinib is a tyrosine kinase inhibitor which acts on several receptors. It functions as an ATP competitor to inhibit tropomyosin receptor tyrosine kinases (TRK) TRKA, TRKB, TRKC, as well as proto-oncogene tyrosine-protein kinase ROS1 and anaplastic lymphoma kinase (ALK).

TRK receptors produce cell proliferation via downstream signaling through the mitogen activated protein kinase, phosphoinositide 3-kinase, and phospholipase C-γ.4 ALK produces similar signalling with the addition of downstream JAK/STAT activation. Inhibition of these pathways suppresses cancer cell proliferation and shifts the balance in favor of apoptosis resulting in shrinking of tumor volume.

At the 109th SEC meeting for Oncology & Haematology, held at CDSCO on March 23rd, 2022, the committee thoroughly examined the proposal presented by Roche Products.

The committee noted that the drug is already approved in the US, EU, Japan, and also the drug is an orphan drug indicated for serious and life threatening diseases and there is an unmet medical need in the country.

In addition, the expert panel noted that the firm has submitted two protocols (Protocol No M041552 & Protocol No BO42777) for permission to conduct two global clinical trials, for which the firm has already received permission (Protocol No M041552) on 14.3.2022

After detailed deliberation, the committee recommended the grant of permission to import and market Entrectinib capsules 100mg and 200mg subject to the condition that the firm should conduct a Phase IV clinical trial in the country in 50 patients for which the protocol should be submitted to CDSCO within two months of approval of the drug for review by the committee.