Roche Products India gets CDSCO Panel Nod To study anti-cancer drug Pralsetinib Capsule

New Delhi: The drug major Roche Products India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical study of the anti-cancer drug Pralsetinib Capsules 100mg.

This came after Roche Products India presented phase I-III clinical study protocol no. BQ42777 version 3.0 dated 15 August 2023

Pralsetinib is a RET receptor tyrosine kinase inhibitor for the treatment of metastatic RET-driven non-small cell lung cancer. Pralsetinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.

Rearranged during transfection (RET) is a transmembrane receptor tyrosine kinase containing extracellular, transmembrane, and intracellular domains whose activity is required for normal kidney and nervous system development. Constitutive RET activation is achieved through chromosomal rearrangements producing 5' fusions of dimerizable domains to the 3' RET tyrosine kinase domain, leading to constitutive dimerization and subsequent autophosphorylation; the most common fusions are KIF5B-RET and CCDC6-RET, although more than 35 genes have been reported to fuse with RET. Constitutive activation leads to increased downstream signaling and is associated with tumor invasion, migration, and proliferation.

Pralsetinib was developed through the screening of more than 10,000 agnostically designed kinase inhibitors, followed by extensive chemical modification to improve its properties.

At the recent SEC meeting for oncology held on June 18, 2024, the expert panel reviewed phase I-III clinical study protocol no. BQ42777 version 3.0 dated, 15 August 2023.

After detailed deliberation, the committee recommended the grant of permission to conduct a phase III clinical study as presented by the firm.

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