IQVIA gets CDSCO panel okay to reopen trial recruitment in the country for Evobrutinib
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New Delhi: Approving IQVIA proposal to amend Phase III Clinical Trail protocol of Bruton's tyrosine kinase (BTK) inhibitor Evobrutinib, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended for the reopening of the trial recruitment in the country with the proposed protocol amendment.
This recommendation came after the firm presented the proposal for protocol amendment 4.0 dated 03-Apr-2022 under the Evolution RMS1 Phase III study protocol no. MS200527_0080 to re-open the trial recruitment in the country.
Evobrutinib is an inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, evobrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways, which leads to the inhibition of the growth of malignant B-cells that overexpress BTK.
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