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MEK inhibitor nears approval
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MEK inhibitor nears approval

› Forums › General Melanoma Community › MEK inhibitor nears approval

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      • January 11, 2013 at 3:01 am
      NYKaren
      Participant
        I wonder what “could be close to reaching the market” really means. Anyone hear anything more specific?
        • January 11, 2013 at 3:01 am
        NYKaren
        Participant
          I wonder what “could be close to reaching the market” really means. Anyone hear anything more specific?
          • January 11, 2013 at 3:01 am
          NYKaren
          Participant
            I wonder what “could be close to reaching the market” really means. Anyone hear anything more specific?
              • January 12, 2013 at 3:09 pm
              lou2
              Participant

                Probably only the FDA knows the answer to your question.  It apparently is in the process of approval, however long that might take.

                Here is a link that gives info on the process:

                http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

                 

                And here is another report on the application, which gives contact info for the maker of the drug:

                August 07, 2012

                NDAs Submitted for Dabrafenib and Trametinib for Unresectable or Metastatic Melanoma

                GlaxoSmithKline announced that it has submitted New Drug Applications (NDAs) for dabrafenib and trametinib to the FDA, seeking approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by an FDA-approved test.

                GlaxoSmithKline entered a collaboration with bioMérieux in 2010 to develop a molecular theranostic test to detect BRAF V600 (V600E and V600K) gene mutations found in several cancers, including melanoma. bioMérieux has filed for FDA Pre-Market Approval of the test and it is currently being utilized in the Phase 3 trametinib-dabrafenib combination program to identify appropriate patients.

                Dabrafenib is a BRAF inhibitor. Trametinib is an MEK inhibitor.

                For more information call (888) 825 5249 or visit http://www.gsk.com.

                • January 12, 2013 at 3:18 pm
                lou2
                Participant

                  I found this on the GSK website, which was interesting because of the opthomologic and cardiac problems reported from the clinical trial on the drug.  Wondering if this info will be available to patients or only to researchers, and whether it applies only in the UK, since it was a British medical journal decision about transparency?

                   

                  http://www.gsk.com/media/press-releases/2012/gsk-responds-bmj-commitment-clinical-trial-data-transparency.html

                  • January 12, 2013 at 10:42 pm
                  NYKaren
                  Participant
                    Interesting, Lou. My my onc says the combo is loaded w/side effects, but he wasn’t specific.
                    • January 12, 2013 at 10:42 pm
                    NYKaren
                    Participant
                      Interesting, Lou. My my onc says the combo is loaded w/side effects, but he wasn’t specific.
                      • January 12, 2013 at 10:42 pm
                      NYKaren
                      Participant
                        Interesting, Lou. My my onc says the combo is loaded w/side effects, but he wasn’t specific.
                        • January 12, 2013 at 3:18 pm
                        lou2
                        Participant

                          I found this on the GSK website, which was interesting because of the opthomologic and cardiac problems reported from the clinical trial on the drug.  Wondering if this info will be available to patients or only to researchers, and whether it applies only in the UK, since it was a British medical journal decision about transparency?

                           

                          http://www.gsk.com/media/press-releases/2012/gsk-responds-bmj-commitment-clinical-trial-data-transparency.html

                          • January 12, 2013 at 3:18 pm
                          lou2
                          Participant

                            I found this on the GSK website, which was interesting because of the opthomologic and cardiac problems reported from the clinical trial on the drug.  Wondering if this info will be available to patients or only to researchers, and whether it applies only in the UK, since it was a British medical journal decision about transparency?

                             

                            http://www.gsk.com/media/press-releases/2012/gsk-responds-bmj-commitment-clinical-trial-data-transparency.html

                            • January 12, 2013 at 3:09 pm
                            lou2
                            Participant

                              Probably only the FDA knows the answer to your question.  It apparently is in the process of approval, however long that might take.

                              Here is a link that gives info on the process:

                              http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

                               

                              And here is another report on the application, which gives contact info for the maker of the drug:

                              August 07, 2012

                              NDAs Submitted for Dabrafenib and Trametinib for Unresectable or Metastatic Melanoma

                              GlaxoSmithKline announced that it has submitted New Drug Applications (NDAs) for dabrafenib and trametinib to the FDA, seeking approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by an FDA-approved test.

                              GlaxoSmithKline entered a collaboration with bioMérieux in 2010 to develop a molecular theranostic test to detect BRAF V600 (V600E and V600K) gene mutations found in several cancers, including melanoma. bioMérieux has filed for FDA Pre-Market Approval of the test and it is currently being utilized in the Phase 3 trametinib-dabrafenib combination program to identify appropriate patients.

                              Dabrafenib is a BRAF inhibitor. Trametinib is an MEK inhibitor.

                              For more information call (888) 825 5249 or visit http://www.gsk.com.

                              • January 12, 2013 at 3:09 pm
                              lou2
                              Participant

                                Probably only the FDA knows the answer to your question.  It apparently is in the process of approval, however long that might take.

                                Here is a link that gives info on the process:

                                http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

                                 

                                And here is another report on the application, which gives contact info for the maker of the drug:

                                August 07, 2012

                                NDAs Submitted for Dabrafenib and Trametinib for Unresectable or Metastatic Melanoma

                                GlaxoSmithKline announced that it has submitted New Drug Applications (NDAs) for dabrafenib and trametinib to the FDA, seeking approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by an FDA-approved test.

                                GlaxoSmithKline entered a collaboration with bioMérieux in 2010 to develop a molecular theranostic test to detect BRAF V600 (V600E and V600K) gene mutations found in several cancers, including melanoma. bioMérieux has filed for FDA Pre-Market Approval of the test and it is currently being utilized in the Phase 3 trametinib-dabrafenib combination program to identify appropriate patients.

                                Dabrafenib is a BRAF inhibitor. Trametinib is an MEK inhibitor.

                                For more information call (888) 825 5249 or visit http://www.gsk.com.

                                • January 15, 2013 at 11:46 pm
                                john partrick michael murphy
                                Participant
                                  I have been taking the MEK inhibitor, with the BRAF inhibitor for over two years, and i would not say “it is loaded with side affects.” I say it is wonderful, with a few mild side affects, and many of my cohorts feel the same way.
                                  • January 15, 2013 at 11:46 pm
                                  john partrick michael murphy
                                  Participant
                                    I have been taking the MEK inhibitor, with the BRAF inhibitor for over two years, and i would not say “it is loaded with side affects.” I say it is wonderful, with a few mild side affects, and many of my cohorts feel the same way.
                                    • January 17, 2013 at 1:08 am
                                    NYKaren
                                    Participant
                                      Dear JPMM,
                                      Thanks for sharing that. Funny, on my last visit to Sloan, both onc & his fellow were saying lots of side-effects for the combo. Go figure.
                                      I wish you ever-lasting response and few to no side effects.
                                      Karen
                                      • January 17, 2013 at 1:08 am
                                      NYKaren
                                      Participant
                                        Dear JPMM,
                                        Thanks for sharing that. Funny, on my last visit to Sloan, both onc & his fellow were saying lots of side-effects for the combo. Go figure.
                                        I wish you ever-lasting response and few to no side effects.
                                        Karen
                                        • January 17, 2013 at 1:08 am
                                        NYKaren
                                        Participant
                                          Dear JPMM,
                                          Thanks for sharing that. Funny, on my last visit to Sloan, both onc & his fellow were saying lots of side-effects for the combo. Go figure.
                                          I wish you ever-lasting response and few to no side effects.
                                          Karen
                                          • January 15, 2013 at 11:46 pm
                                          john partrick michael murphy
                                          Participant
                                            I have been taking the MEK inhibitor, with the BRAF inhibitor for over two years, and i would not say “it is loaded with side affects.” I say it is wonderful, with a few mild side affects, and many of my cohorts feel the same way.
                                          • January 13, 2013 at 1:48 am
                                          Wife of Carl
                                          Participant

                                            My husband has been on a clinical trial for the GSK MEK inhibitor for 2 1/2 years.  His doctor said that he got notice from GSK that it would be on the market this spring.

                                            Pat

                                            • January 13, 2013 at 1:48 am
                                            Wife of Carl
                                            Participant

                                              My husband has been on a clinical trial for the GSK MEK inhibitor for 2 1/2 years.  His doctor said that he got notice from GSK that it would be on the market this spring.

                                              Pat

                                              • January 13, 2013 at 1:48 am
                                              Wife of Carl
                                              Participant

                                                My husband has been on a clinical trial for the GSK MEK inhibitor for 2 1/2 years.  His doctor said that he got notice from GSK that it would be on the market this spring.

                                                Pat

                                                  • January 13, 2013 at 2:03 am
                                                  NYKaren
                                                  Participant
                                                    Hi Pat,
                                                    Is he on the MEK inhibitor alone or in combo with the BRAF inhibitor?
                                                    • January 13, 2013 at 2:03 am
                                                    NYKaren
                                                    Participant
                                                      Hi Pat,
                                                      Is he on the MEK inhibitor alone or in combo with the BRAF inhibitor?
                                                      • January 13, 2013 at 6:42 pm
                                                      Wife of Carl
                                                      Participant

                                                        He is on the MEK inhibitor alone.

                                                        • January 13, 2013 at 6:42 pm
                                                        Wife of Carl
                                                        Participant

                                                          He is on the MEK inhibitor alone.

                                                          • January 13, 2013 at 6:42 pm
                                                          Wife of Carl
                                                          Participant

                                                            He is on the MEK inhibitor alone.

                                                            • January 13, 2013 at 2:03 am
                                                            NYKaren
                                                            Participant
                                                              Hi Pat,
                                                              Is he on the MEK inhibitor alone or in combo with the BRAF inhibitor?
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