Natco Pharma gets CDSCO nod to manufacture, market anti neoplastic drug Idelalisib

This nod is subjected to condition that the 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.

In addition to this, the expert panel directed the firm that the drug should be sold by retail under the prescription of the Oncologist only.

This came after the drug maker Natco Pharma presented a proposal for manufacturing and marketing of Idelalisib 150mg & 100mg Tablets with local clinical trial waiver and result of bioequivalence (BE) study before the committee.

Idelalisib is an anti-neoplastic oral kinase inhibitor that is approved for use in combination with rituximab in relapsed or refractory chronic lymphocytic leukemia (CLL) and as monotherapy for relapsed follicular B cell and small lymphocytic lymphoma.

Idelalisib is associated with a high rate of minor serum enzyme elevations during therapy and has been reported to cause clinically apparent acute liver injury that can be severe and even fatal.

Idelalisib specifically inhibits P110δ, the delta isoform of the enzyme phosphatidylinositol-4,5-bisphosphate 3-kinase, also known as PI-3K. The PI-3Ks are a family of enzymes involved in cellular functions such as cell growth, proliferation, differentiation, motility, survival, and intracellular trafficking, which in turn are involved in cancer. In contrast to the other class IA PI3Ks p110α and p110β, p110δ is principally expressed in leukocytes (white blood cells) and is important for the function of T cells, B cell, mast cells, and neutrophils. By inhibiting this enzyme, idelalisib induces apoptosis of malignant cells and inhibits several cell signaling pathways, including B-cell receptor (BCR) signaling and C-X-C chemokine receptors type 5 and type 4 signaling, which is involved in trafficking and homing of B-cells to the lymph nodes and bone marrow.

At the 120th SEC meeting for Oncology and Hematology held on 9th March 2022, the committee extensively reviewed the proposal presented by the drug maker Natco Pharma for the manufacturing and marketing of the anti-Neoplastic drug Idelalisib 150mg &100mg with local clinical trial waiver and result of BE study

The committee noted, that the drug is already approved in countries like the US, EU, Canada, and also the drug is an orphan drug & indicated for serious and life-threatening disease and there is an unmet medical need in the country.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Idelalisib 150mg & 100mg for the proposed indication subject to the condition that the 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.

In addition, the committee opined that the drug should be sold by retail under the prescription of the Oncologist only.