› Forums › Cutaneous Melanoma Community › Tafinlar, Mekinist approved for metastatic melanoma treatment in Canada
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john partrick michael murphy.
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- July 25, 2013 at 11:43 am
Tafinlar, Mekinist approved for metastatic melanoma treatment in Canada
Dabrafenib and trametinib have been approved by Health Canada for treating patients with unresectable or metastatic melanoma, manufacturer GlaxoSmithKline announced today.
Tafinlar, Mekinist approved for metastatic melanoma treatment in Canada
Dabrafenib and trametinib have been approved by Health Canada for treating patients with unresectable or metastatic melanoma, manufacturer GlaxoSmithKline announced today.
Dabrafenib (Tafinlar), a BRAF inhibitor, and trametinib (Mekinist), a MEK inhibitor, are each indicated as monotherapy oral treatment for patients with BRAF V600 mutation, according to a press release. A validated test to identify BRAF V600 mutation status is required.
Available dosage will be 50 mg and 75 mg capsules for dabrafenib and 0.5 mg and 2.0 mg tablets for Mekinist, according to GlaxoSmithKline (GSK).
“Health Canada’s approval of Tafinlar and Mekinist represent an important step in GSK’s ongoing effort to bring new treatment options to cancer patients as quickly and efficiently as possible,” Rav Kumar, PhD, vice president of R&D Operations/Business Development, GSK Canada, said in the release.
Earlier this month, GSK announced it had submitted supplemental New Drug Applications to the FDA for dabrafenib in combination with trametinib as therapy for metastatic or unresectable melanoma. The FDA announced in May that it had approved dabrafenib to treat patients whose tumors express BRAF V600E gene mutation and trametinib for patients whose tumors express BRAF V600E or V600K gene mutations. The drugs were not approved as combination therapy.
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- July 31, 2013 at 4:25 am
There it is! This came as a result of my trial, and those that came before. What a great feeling! Soon it should be approved as a combo here in the US. I think our trial was set up for two years, but many of us are doing real well after we hit the two year mark. To see where we would be without the combo, Google “NYT melanoma Flaherty” and read the three part story of the first ten heroes who only had the BRAF inhibitor. Since so many of us are undead they now did a “rollover” and now I think it will not end until they have complete morbidity. I plan on dying from something else, so long as GSK keeps giving us those special pills and capsules. Today marks the 945th day this fourth stager has survived, and thrived on their life prolonging meds. You should be proud GSK. I have no way to properly thank you and your talented researchers. -
- July 31, 2013 at 4:25 am
There it is! This came as a result of my trial, and those that came before. What a great feeling! Soon it should be approved as a combo here in the US. I think our trial was set up for two years, but many of us are doing real well after we hit the two year mark. To see where we would be without the combo, Google “NYT melanoma Flaherty” and read the three part story of the first ten heroes who only had the BRAF inhibitor. Since so many of us are undead they now did a “rollover” and now I think it will not end until they have complete morbidity. I plan on dying from something else, so long as GSK keeps giving us those special pills and capsules. Today marks the 945th day this fourth stager has survived, and thrived on their life prolonging meds. You should be proud GSK. I have no way to properly thank you and your talented researchers. -
- July 31, 2013 at 4:25 am
There it is! This came as a result of my trial, and those that came before. What a great feeling! Soon it should be approved as a combo here in the US. I think our trial was set up for two years, but many of us are doing real well after we hit the two year mark. To see where we would be without the combo, Google “NYT melanoma Flaherty” and read the three part story of the first ten heroes who only had the BRAF inhibitor. Since so many of us are undead they now did a “rollover” and now I think it will not end until they have complete morbidity. I plan on dying from something else, so long as GSK keeps giving us those special pills and capsules. Today marks the 945th day this fourth stager has survived, and thrived on their life prolonging meds. You should be proud GSK. I have no way to properly thank you and your talented researchers.
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Tagged: cutaneous melanoma
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