HER2 Support Group Forums - View Single Post - FDA Blocks Life-Saving Cancer Drug Rally

fullofbeans · 02-09-2012, 04:17 PM

Being the devil's advocat: Another example that may be used although I do think that Tdm1 has much more proof..

..should there be new regulation for people that have exhausted standard therapy..or say third line therapy..

http://en.wikipedia.org/wiki/Gemtuzumab_ozogamicin

Gemtuzumab ozogamicin (marketed by Wyeth as Mylotarg) is a drug-linked monoclonal antibody that was used to treat acute myelogenous leukemia from 2000-2010. It was withdrawn from market in June 2010 when a clinical trial showed the drug increased patient death and added no benefit over conventional cancer therapies.

Gemtuzumab is a monoclonal antibody to CD33 linked to a cytotoxic agent from the class of calicheamicins. CD33 is expressed in most leukemic blast cells but also in normal hematopoietic cells, the intensity diminishing with maturation of stem cells. In the United States, it was approved under an accelerated-approval process by the FDA in 2000 for use in patients over the age of 60 with relapsed acute myelogenous leukemia (AML); or those who are not considered candidates for standard chemotherapy.[1]

02-09-2012, 04:17 PM	#19
fullofbeans Senior Member Join Date: Jan 2007 Location: UK Posts: 617	Re: FDA Blocks Life-Saving Cancer Drug Rally Being the devil's advocat: Another example that may be used although I do think that Tdm1 has much more proof.. ..should there be new regulation for people that have exhausted standard therapy..or say third line therapy.. http://en.wikipedia.org/wiki/Gemtuzumab_ozogamicin Gemtuzumab ozogamicin (marketed by Wyeth as Mylotarg) is a drug-linked monoclonal antibody that was used to treat acute myelogenous leukemia from 2000-2010. It was withdrawn from market in June 2010 when a clinical trial showed the drug increased patient death and added no benefit over conventional cancer therapies. Gemtuzumab is a monoclonal antibody to CD33 linked to a cytotoxic agent from the class of calicheamicins. CD33 is expressed in most leukemic blast cells but also in normal hematopoietic cells, the intensity diminishing with maturation of stem cells. In the United States, it was approved under an accelerated-approval process by the FDA in 2000 for use in patients over the age of 60 with relapsed acute myelogenous leukemia (AML); or those who are not considered candidates for standard chemotherapy.[1] __________________ 35 y/o June 06: BC stage I Grade 3; ER/PR neg Her-2+++; lumpectomies Aug 06: Stage IV liver mets: 6 tumours July 06 to Jan 07: 2FEC+6Taxotere; 3TACE; LITT March 07- Sept 07: Vaccination trial (phase 2, peptide based) at the UW (Seattle). Herceptin since 2006 NED til Oct 09 Recurrence Oct 2009: to internal mammary gland since October 2009 missed on Oct and March 2010 scan.. palpable nodes in May 2010 when I realised.. Nov 2011:7 mets to lungs progressing fast failed hercp/tykerb/xeloda combo.. superior vena cava blocked: stent but face remains puffy April 2012: Teresa Trial, randomised to TDM1 Nov 2012 progressing on TDM1 Dec 2012 blockage of my airways by tumours, obliteration of these blocking tumours breathing better but hoping for more- at mo too many tumours to count in the lungs and nodes. Dec 2012 Starting new trial S-222611 phase 1b dual egfr her2+ inhibitor. 'Under no circumstances should you lose hope..' Dalai Lama Last edited by fullofbeans; 02-09-2012 at 04:28 PM..*