CDSCO Panel denies Nacto Pharma's request To Waive Phase III CT of Anticancer Erdafitinib tablet

This came after Natco Pharma presented their proposal for a grant of permission to manufacture and market Erdafitinib Tablets 3mg, 4mg, and 5mg along with bioequivalence study data as well as a Phase III clinical trial study waiver.

Erdafitinib is a fibroblast growth factor receptor tyrosine kinase inhibitor used to treat locally advanced or metastatic urothelial carcinoma.

Fibroblast growth factor receptor (FGFR) is a transmembrane protein that is expressed ubiquitously in normal tissues and is involved in various endogenous bio-physiological processes including the homeostasis of phosphate and vitamin D, cell proliferation, cell anti-apoptotic signaling, and cell migration in a variety of cell types.

Concurrently, genetic mutations such as gene amplification, point mutations, and chromosomal translocations of all four FGFR genes (FGFR1, FGFR2, FGFR3, and FGFR4) or deregulation of FGFR pathways have been implicated in the pathogenesis of various cancers, including urothelial cancer, as they promote cell proliferation, migration, angiogenesis, and anti-apoptosis.

Erdafitinib is an oral selective pan-FGFR kinase inhibitor that binds to and inhibits the enzymatic activity of expressed FGFR1, FGFR2, FGFR3, and FGFR4 based on in vitro data.

In particular, erdafitinib demonstrates inhibition of FGFR phosphorylation and signaling as well as decreased cell viability in cell lines expressing FGFR genetic alterations.

Erdafitinib demonstrated antitumor activity in FGFR-expressing cell lines and xenograft models derived from tumor types, including bladder cancer.

At the recent SEC meeting for Oncology and Hematology held on 25th July 2023, the expert panel reviewed the proposal presented by Natco Pharma for the grant of permission to manufacture and market Erdafitinib Tablets 3mg, 4mg, and 5mg along with bioequivalence study data as well as Phase III clinical trial study waiver.

After detailed deliberation, the committee did not recommend the waiver of the Phase III clinical trial.

Accordingly, the expert panel stated that the firm should submit the Phase III clinical trial protocol before the committee for further consideration.

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