Novartis gets CDSCO Panel nod to market anticancer drug Trametinib and Dabrafenib for additional indication
New Delhi: In a significant development, the drug major Novartis has got a go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market anticancer drug Trametanib in combination with Dabrafenib for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
This came after the drug major Novartis presented their proposal for import and marketing of Trametanib Tablets 0.5 mg, 2.0 mg and Debrafenib Capsules 50mg, 75mg for additional indication along with their justification, rationale for proposed indication, global approval status and outcome of some clinical trial data before the committee.
Trametinib belongs to a group of medicines called kinase inhibitors. It is prescribed for the treatment of a certain type of advanced-stage skin cancer (melanoma) that has spread to other parts of the body or which cannot be treated by surgery. Trametinib is often given in combination with dabrafenib for patients with BRAF V600E or V600K mutations. It prevents the growth of cancer cells by blocking the MEK proteins which signals them to multiply.
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