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.
Dabrafenib and trametinib are types of cancer growth blockers. They work by targeting certain proteins that help cancer cells grow. By blocking these proteins, this combination of drugs stops or slows down the growth of cancer cells.
Dabrafenib in combination with trametinib acts by binding with BRAF and MEK inhibitors, generating a blockade point in the MAPK pathway at two different levels, inhibiting oncogenic downstream signaling and causing cell cycle arrest.
The U.S. Food and Drug Administration approved Dabrafenib(Tafilnar) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive)
At the recent SEC meeting for Oncology and Hematology held on 22nd December 2022, the expert panel reviewed the proposal presented by the drug maker Novartis for importing and marketing the anticancer drug Trametanib tablets 0.5mg and 2.0mg, Dabrafenib 50mg and 75mg for an additional indication.
After detailed deliberation, the committee recommended the grant to import and market Trametanib Tablets 0.5 mg, 2.0 mg and Debrafenib Capsules 50mg, 75mg 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.
