Archive | Regulatory

FDA approves ‘precision medicine’ drug for different cancers with same mutation

Source: The Washington Post, January 2019 The Food and Drug Administration on Monday approved a drug for a wide range of cancers based on a shared mutation, rather than the tumors’ locations — an advance for the sometimes controversial field of “precision medicine.” The medication, called Vitrakvi, is the second treatment to receive FDA clearance […]

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CHMP Favors EU Approval of Keytruda for Advanced Melanoma Patients with Complete Tumor Resection

Source: Immuno-oncology News, December 2018 The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Keytruda(pembrolizumab) for the treatment of advanced melanoma patients whose tumor has been completely removed in surgery. The European Commission will now review CHMP’s opinion before making a final decision regarding […]

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BRIEF—Health Canada added approval for Tafinlar plus Mekinist combo

Source: The Pharma Letter, December 2018 Pharma regulator Health Canada has approved the use of a combination of two Novartis cancer therapies as targeted treatment to prevent recurrence of melanoma following surgery, also referred to as adjuvant treatment. The combination of Tafinlar (dabrafenib) and Mekinist (trametinib) has been approved for the adjuvant treatment of patients […]

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European Commission approves BRAFTOVI and MEKTOVI to treat advanced BRAF-mutant melanoma

Source: Hospital Healthcare Europe, October 2018 The European Commission (EC) had approved the use of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) to treat adults with advanced BRAF-mutant melanoma. The EC’s decision is based on results from the Phase 3 COLUMBUS trial, which demonstrated 14.9 months median progression-free survival and 33.6 months median overall survival with the combination […]

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Posted in Melanoma News, Regulatory, Publications