CDSCO Panel approves Roche's Protocol Amendment proposal to study Entrectinib
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Roche's protocol amendment proposal for the clinical trial protocol titled, "Randomized, open label, multicenter, phase III study of Entrectinib versus Crizotinib in patients with locally-advanced or metastatic non-small cell lung cancer harboring ROS1 gene rearrangements with and without central nervous system metastases."
This came after the firm presented protocol amendment version 6 dated 02.10.2023 protocol no. MO41552.
The study will compare the efficacy and safety of Entrectinib with Crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral Entrectinib or Crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
Entrectinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. 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, and TRKC, as well as proto-oncogene tyrosine-protein kinase ROS1 and anaplastic lymphoma kinase (ALK).
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