Novartis Healthcare gets CDSCO panel nod to market anti cancer drug Dabrafenib
New Delhi: In a significant development, pharmaceutical major Novartis Healthcare has got a go ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to import and market anti cancer drug Dabrafenib capsules 50 mg and 75 mg.
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.
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