HER2 Support Group Forums - View Single Post - What can we do about the delay of TDM-1

hutchibk · 09-05-2010, 04:34 PM

I spoke to the Genentech clinical trial support line on Thur and Fri (at 4 pm cst on Friday) and they say they have heard no word at all that the EAP will be curtailed or discontinued, and they are still pre-screening folks for the current locations. One other thing I seem to remember that I learned is that they are only planning on accruing 200 total across the country for the EAP. I can't for the life of me remember who told me that, but it was on Thur (since I talked to Genentech support and to an EAP location coordinator... can't remember who said it). The last person I spoke to at Genentech support told me she had 8 new locations that were pending for EAP, awaiting full approval...

I wouldn't be at all surprised to hear word soon that the EAP might be suspended. I certainly wouldn't blame them if they decide to suspend for now and re-open it around the time in 2012 that they plan to submit the BLA again... I believe it is designed as a 'bridge' for mets patients to help carry them over to full market approval, and now that that has been set back, it would be an expensive proposition to continue accruing the program for 2-3 years as opposed to 6-8 months that I think they believed would be their accelerated timeline to market.

Just one girls opinion.

09-05-2010, 04:34 PM	#25
hutchibk Senior Member Join Date: Oct 2005 Posts: 3,519	Re: What can we do about the delay of TDM-1 I spoke to the Genentech clinical trial support line on Thur and Fri (at 4 pm cst on Friday) and they say they have heard no word at all that the EAP will be curtailed or discontinued, and they are still pre-screening folks for the current locations. One other thing I seem to remember that I learned is that they are only planning on accruing 200 total across the country for the EAP. I can't for the life of me remember who told me that, but it was on Thur (since I talked to Genentech support and to an EAP location coordinator... can't remember who said it). The last person I spoke to at Genentech support told me she had 8 new locations that were pending for EAP, awaiting full approval... I wouldn't be at all surprised to hear word soon that the EAP might be suspended. I certainly wouldn't blame them if they decide to suspend for now and re-open it around the time in 2012 that they plan to submit the BLA again... I believe it is designed as a 'bridge' for mets patients to help carry them over to full market approval, and now that that has been set back, it would be an expensive proposition to continue accruing the program for 2-3 years as opposed to 6-8 months that I think they believed would be their accelerated timeline to market. Just one girls opinion. __________________ Brenda NOV 2012 - 9 yr anniversary JULY 2012 - 7 yr anniversary stage IV (of 50...) Nov'03~ dX stage 2B Dec'03~ Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive Jan'04~ Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo. Sept'05~ micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only Aug'06~ micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin Feb'07~ Genetic testing, BRCA 1&2 neg Apr'07~ MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin May'07~ Started Tykerb/Xeloda, no WBR for now June'07~ MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic! Aug'07~ MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2 Oct'07~ PET/CT & MRI show NED Apr'08~ scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone) Sept'08~ MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers Oct'08~ dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion Dec'08~ Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable June'09~ new 3-4mm left cerrebellar spot zapped with IMRT targeted rads Sept'09~ new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors. Oct'09~ 25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen. Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen. June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen. Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice. Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots. Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011. Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah. "I would rather be anecdotally alive than statistically dead." Last edited by hutchibk; 09-05-2010 at 04:37 PM..