Submit Phase IV CT protocol: CDSCO Panel tells Roche over Anti-Cancer drug Pralsetinib

This came after the firm was granted permission to import and market Pralsetinib Capsules 100mg subject to the condition that firm should conduct a Phase IV clinical trial for which protocol should be submitted within 3 months of approval of the drug for review by the committee.

However, the expert panel observed that the firm presented its request for consideration of an alternative approach to Phase IV clinical trial.

Pralsetinib is a RET receptor tyrosine kinase inhibitor for the treatment of metastatic RET-driven non-small cell lung cancer. Pralsetinib is indicated for treating metastatic non-small cell lung cancer (NSCLC) in adult patients who are confirmed to possess a rearranged during transfection (RET) gene fusion, as determined by an FDA-approved test.

It is also indicated in adult and pediatric patients 12 years of age and older for the treatment of advanced or metastatic RET-mutant medullary thyroid cancer, and in this same population for the treatment of advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and for whom radioactive iodine is not appropriate.

Pralsetinib is a RET receptor tyrosine kinase inhibitor for the treatment of metastatic RET-driven non-small cell lung cancer. RET is an abbreviation for "rearranged during transfection", as the DNA sequence of this gene was originally found to be rearranged within a 3T3 fibroblast cell line following its transfection with DNA taken from human lymphoma cells. The human gene RET is localized to chromosome 10. Rearranged during transfection (RET) is a transmembrane receptor tyrosine kinase. It constitutes extracellular, transmembrane, and intracellular domains whose activity is required for normal kidney and nervous system development. Constitutive RET activation further leads to elevated downstream signalling and is associated with tumour invasion, migration, and proliferation.

At recent SEC meeting for Oncology & Haematology, the expert panel reviewed the firm's request for consideration of an alternative approach to Phase IV clinical trial of the anti-neoplastic drug Pralsetinib.

The committee noted that the firm proposed the following alternative approach to Phase IV CT:

1. The participation of Indian centres in 5 Phase III global clinical trials would include 61 Indian patients.

2. The voluntary conduct of Real World Evidence Basket study for tumour and rare condition (TARC) in 40 patients.

After detailed deliberation, the committee reiterated its earlier recommendation and stated,

'The firm should submit Phase IV clinical trial protocol before the committee."

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