Novartis to get approval for import and marketing of Dabrafenib, anticancer medicine for additonal indication from CDSCO. Subject Expert committee recommends CDSCO for grant of permission to import and marketing of Dabrafenib capsules 50 mg and 75 mg.
Novartis 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, sold under the brand name Tafinlar & Rafinlar among others, is a medication for the treatment of cancers associated with a mutated version of the gene BRAF. Dabrafenib acts as an inhibitor of the associated enzyme B-Raf, which plays a role in the regulation of cell growth.
The committee noted that the drug is already approved in US, Australia & Singapore etc. for one proposed additional indication. As well as in US, EU, Japan, Canada etc for another additional indication.
After detailed deliberation, the committee recommended for grant of permission to import and marketing of Dabrafenib capsules 50 mg and 75 mg in combination with trametinib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory loco regional treatment options; and adjuvant treatment of patients with melanoma with BRAF V600E orV600K mutations, as detected by an appropriate test, and involvement of lymphnodes, following complete resection.
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