Submit Phase IV CT protocol for Entrectinib: CDSCO panel tells Roche India
New Delhi: Rejecting the drug major Roche's alternative proposal to the Phase IV clinical trial of anti-cancer Entrectinib capsules of 100 mg and 200 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has reiterated its earlier recommendation and directed the firm to submit the Phase IV clinical trial protocol before the committee.
This came after the firm presented its request for consideration of an alternative proposal to the Phase IV clinical trial of the anticancer drug Entrectinib 100 and 200 mg capsules.
Entrectinib is a tyrosine kinase inhibitor that 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.
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