Novartis Healthcare gets CDSCO panel nod to market anti cancer drug Dabrafenib

This came after the firm presented their proposal for import and marketing of the drug Dabrafenib capsules 50 mg and 75 mg for an additional indication, along with justification for clinical trial waiver before the committee.

Dabrafenib is a kinase inhibitor used to treat patients with specific types of melanoma, non-small cell lung cancer, and thyroid cancer. Dabrafenib is an orally bioavailable inhibitor of B-raf (BRAF) protein with antineoplastic activity. Dabrafenib selectively binds to and inhibits the activity of B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. B-raf belongs to the raf/mil family of serine/threonine protein kinases and plays a role in regulating the MAP kinase/Extracellular Signal-regulated Kinases signaling pathway, which may be constitutively activated due to BRAF gene mutations.

In December 2021, Novartis entered into market development agreement with BeiGene, granting BeiGene rights to market, promote and detail five approved Novartis oncology products, TAFINLAR (dabrafenib), MEKINIST (trametinib), VOTRIENT (pazopanib), AFINITOR (everolimus), and ZYKADIA (ceritinib).

At recent SEC meeting for oncology & haematology, dated 9.02.2022 the committee extensively reviewed the proposal presented by drug-maker Novartis to import and market the drug Dabrafenib capsules 50 mg and 75 mg for an additional indication, along with justification for clinical trial waiver before the committee.

The committee noted that the drug is already approved in US, EU, Japan, Canada etc for the proposed additional indication.

After detailed deliberation, the committee recommended the grant of permission to import and marketing of Dabrafenib capsules 50 mg and 75 mg for the following indication Dabrafenib in combination with trametinib for the adjuvant treatment of patients with melanoma with BRAF V600E orV600K mutations, as detected by an appropriate test, and involvement of lymphnode (s), following complete resection.