Pushing this up from TDM1 thread

[michka]

I am pushing this message from Schoonder up as it may not be very visible at the end of the TDM1 thread. It seems important. Michka.

schoonder
Senior Member

Join Date: Jul 2008
Posts: 78
Re: T-DM! Expanded Access is Here !!!
Phil McMartin and his wife Lorraie were featured on a front page Boston Globe article. TDM-1 is the only treatment option Lorraine has but she must travel to VA for it because it is not offered in MA.
Phil writes:
My wife and I have gone to Capitol Hill once before to meet with Sen. Kerrys and Rep. Stephen Lynchs staff about our struggle to get T DM-1 expanded access to Boston. Many of you read our story in the Boston Globe, Jan. 5th. After the article came out, Sen. Kerry sent a blunt letter to the FDA. We are trying to keep up the pressure.
From the beginning last Sept., our congressmens staff have been very responsive. Contacting the FDA, and Genentech ,asking questions. How can you give access to someone in Va., but not in Boston ?, etc. I believe their questions helped influence Genentech to not stop ALL Expanded Access across the country as of last Oct. 31, as Gen. planned to do. Unfortunately, they have not extended access to Boston, New York, New Jersey, or all New England, yet . It has been 5 months plus.

Now we will meet with the " HELP " Committee, which oversees the FDA. After all, if the FDA hadn't made the mind-boggling decision to decline approval, we wouldn't be having this discussion !
So, any HER2 survivor out there who was denied access in NY, New England last Sept. 1 , and is still waiting, e mail me at pmccartinjr[at]comcast[dot]net. Tell me a short version of your struggle, any progression since Sept. 1, side -effects that you suffer with, etc. Give me contact info, and I will give your stories to the HELP Committee.
Oh, and include your congressmen/womens' names. Call your congressional reps, ask for the healthcare issue aide, and e-mail them the same report. ( You can find your reps on the Komen web-site, under the advocacy alliance. )

[schoonder]

Thanks for starting this thread Michka.
Phil is surprised by how little response he has received so far from patient population in need of this drug. Here's link to this T-DM1's advocate recent

posthttp://community.breastcancer.org/forum/8/topic/763725?page=1#post_2192378

which reads:

"Hi, this is Phil. thanks to English major for the post about our next trip, to get T DM-1 in Va. Mon. to Wed. this week. We have heard from 2 more HER2 patients. One has traveled from Boston to Va., just like we did. So, thats 4 patients in Boston who need it here. I'm sure there are more. Back in October, a nurse at Farber told us there were 100 women waiting for T DM-1 there. I am still puzzled by not hearing from any women in the NY area ?
Where are the advocacy groups ? NBCC , which fought for the original Herceptin in the 1990's, ACS, Komen ? I've contacted all 3, no help.
I spend most of my time on Inspire, so contact me there. To the FDA : Approve Now, Test Later."

Hope Phil is successfull when he meets with
The United States Senate Committee on Health, Education, Labor, and Pensions (HELP) which considers matters relating to health, education, labor, and pensions.
Surely help from any and all her2board members would be greatly appreciated.

[phil]

Actually, we now have heard from 8 women who need the drug in boston. One other woman, chris, has followed us to Va. I know there are other women out there. The effort with Congresss seems to have stalled. They think this FDA Administration is going to correct itself. We need the Presidents HHS Secretary, Dr. Sebelius, to look into it. After getting exp. access extended in-definitely. Which is an accomplishment, but we want so much more. Approval. So, we did an interview with Ch. 5 , ABC, here in Boston. The interview should air this week. I will try to give heads up when it airs. Hopefully willl stir up more advocacy. Where are the advocacy groups ? We need them to lobby for us, they should support us, not worry about appearing to endorse adrug. This is a breakthrough drug, and it calls for advocates to speak out. A drug like this comes along once every 10 years. With a better system, they will come along alot more quickly. Changes will benefit all cancer pts.
Those of you who know ACS, Komen, NBCC advocates, send them the Globe article, and my e-mail, pmccartin@comcast.net. 40% " COMPLETE or significant " tumor reduction , at the end of Phase II trials - thats un-believable !
I challenge the FDA to name a drug with better stats at that stage. Many lesser drugs were granted Accelerated Approval . Somebody's trying to cut costs, and cant admit they made a mistake. Never actually talked with a patient whose life was saved by the drug. Thats got to change.

[schoonder]

Abstract 1761 this April's AACR conference shows that t-dm1 with pertuzumab did quite well in preclinical her2+ gastric evaluations.

[ElaineM]

If you go to clinicaltrials.gov and then type T DM1 in the search box you will get a list of T DM1 trials available. Click on one that interests you to get the details, including a list of the locations where it is available. Just because the expanded access program might not be totally available to alot of people there are other T DM1 trials recruiting people.
After you find one that interests you work with your doctor to connect to the authorities at a location near you or contact them directly to get more information, consent forms or make arrangements to participate.
Just maybe if enough people participate in these trials T DM1 has a better chance of going through the FDA process in a timely manner, so that even more people can receive the drug.

[Nancy L]

Good for you Phil. I very much appreciate your advocacy. The FDA is high on my list of federal agencies in desperate need of reform. T DM1 is the first drug Dr. Slamon mentioned he would consider using on me when Tykerb stops working. I live in California and have no confidence that either of our senators (who are both women) would be helpful. Since Genentech has announced Avastin is going to get a retrial with the FDA, maybe they can just take care of T DM1 at the same time. Wouldn't it be nice if they could be that efficient?

[phil]

Expanded access to T DM-1 is available at 13 sites around the country. Access requires only 2 week " wash-out " vs. a month for trials.Call Genetech for asite near you, 888-662-6728. The closest site to NY, New England is in Fairfax, Va.

[hutchibk]

http://www.clinicaltrials.gov/ct2/sh...%2F2010&rank=1


Investigational Site Highland, California, United States, 92346
Investigational Site Stockton, California, United States, 95204
Investigational Site Denver, Colorado, United States, 80220
Investigational Site Davie, Florida, United States, 33328
Investigational Site Chicago, Illinois, United States, 60612
Investigational Site Lafayette, Indiana, United States, 47905
Investigational Site Cedar Rapids, Iowa, United States, 52403
Investigational Site Louisville, Kentucky, United States, 40245
Investigational Site Detroit, Michigan, United States, 48201
Investigational Site St. Louis, Missouri, United States, 63141
Investigational Site Charleston, South Carolina, United States, 29403
Investigational Site Nashville, Tennessee, United States, 37203
Investigational Site San Antonio, Texas, United States, 78229
Investigational Site Fairfax, Virginia, United States, 22031

Criteria
Inclusion Criteria:

• Histologically or cytologically documented breast cancer
• Locally advanced or metastatic breast cancer
• HER2-positive breast cancer documented as FISH-positive, IHC 3 + or CISH-positive by local laboratory assessment
• Prior treatment with an anthracycline and a taxane given in the neoadjuvant, adjuvant, or metastatic setting, or as treatment for unresectable locally advanced disease
• Prior treatment with capecitabine or infusional 5-fluorouracil and at least two HER2-targeted agents, including trastuzumab and lapatinib, in the metastatic and/or unresectable locally advanced setting
• Patients must have had disease progression during their most recent treatment regimen
• Adequate hematologic and end organ function
• Agreement to use an effective form of birth control throughout the study
• Life expectancy ≥ 90 days as assessed by the investigator

Exclusion Criteria:

• Less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy
• Prior T-DM1 therapy
• History of exposure to cumulative doses of select anthracyclines
• History of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued
• Brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment
• Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, at the time of the first study treatment
• History of clinically significant cardiac dysfunction
• Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
• Current severe, uncontrolled systemic disease
• Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment
• Pregnancy or lactation

I personally believe this lies mostly in the hands/blame of the FDA for applying extremely binding overall survival criteria (which they also insanely qualified by stating "regardless of HER2 status", WTF?) for approval that they don't/haven't necessarily require(d) for drugs for other cancers as well as for other breast cancer drugs...

I imagine that Genentech/Roche and the makers of Maytanzine 1) simply can't afford to offer it in compassionate use for an indeterminate amount of time to a full complement of locations 2) aren't able to manufacture enough of it to offer in compassionate use as well as all the trials for an indeterminate amount of time... due to the FDA rejection of the BLA in July. I believe they intended to open it up to compassionate use to bridge the period of time it would take for the FDA to approve it and license it, which they expected to be a 6 mo to 1 yr process at the longest. They do not want to close the EAP, but they need to keep it limited and small in scope because they don't expect to be allowed to go back for approval for 18 months or more at this point.

[hutchibk]

I will be traveling to Denver to get mine... and am happy to do so, even though it will put a strain on the budget. The doctor there is so incredible and a Her2BC specialist that I know it will be worth it. I could drive to San Antonio which is closer, but the clinic and care there don't work for me or impress me. I prefer Denver and think it is well worth the trip, the Rose location of Rocky Mountain Cancer Clinic, and the staff, are just incredibly top notch. I shopped flights to Denver or Nashville which are the closest to me, and Denver was cheaper. I will also be looking into programs that assist with patients needing to travel/fly to distant locations for treatment/trials.

[ElaineM]

I wonder if the American Cancer Society can suggest ways you can get cheaper fares to Denver?
I also wonder if these resources sources actually work?
Free Air Travel for Patients and Their Families (top)
Patient.org and its related help-line serves to make referrals and provide assistance for any financially challenged patient needing to travel to a distant specialized medical facility for evaluation, diagnosis, or treatment. Patients and their accompanying family members may make multiple trips back and forth to distant specialized care and there is no age limit. If the travel distance is 1000 miles or less, a referral will be made to an Angel Flight America program where 4000 volunteer pilots are available to provide private or corporate aircraft travel at no cost. If the patient must travel more than 1000 miles or is unable to fly on light aircraft, a referral is made to the most appropriate, charitable airline ticket program. These programs provide free or highly discounted reduced-rate tickets. The National Patient Ticket HELPLINE is staffed Monday through Friday 9 a.m. -5 p.m. Eastern time. After hours, a message recorder is available and response time is 10 minutes, if the message is urgent. Contact PatientTravel.org, Mercy Medical Airlift, 4620 Haygood Road, Suite 1, Virginia Beach, VA 23455; 757-318-9174; 800-296-1217 (toll-free); Fax: 757-318-9107; National Patient Ticket HELPLINE: 1-800-325-8908; {mercymedical@erols.com}; {www.patientravel.org}.
Air Care Assistance (top)
The Air Care Alliance is a nationwide organization of those pilots who volunteer to fly to provide assistance for health care, patient transportation or other volunteer missions. The website provides a listing of programs providing medical transportation, non-patient transports, and ways to volunteer. To locate information on the program near you, contact Air Care Alliance, 6202 South Lewis Ave., Suite F2, Tulsa, OK 74136; 918-745-0384; 888-260-9707; {www.aircareall.org}.

[hutchibk]

Thx Elaine! I do have a patient navigator at Livestrong who is helping me do this research and find all the programs, as well as a friend/coordinator at my local Breast Cancer Resource Center. I will make sure they know about these as well...

I know one of the program that is put together by private pilots who donate their time and planes is one that they use private Cessnas and Pipers, etc, (not pressurized cabins) which I totally appreciate but can't fly in... not because of non-pressurized, but because I lost my brother and his family of 4 in a small plane crash in 2001 and they scare the crap out of me now, especially for long distance travel...

Southwest Airlines has a grant program that they offer every year through the clinics that offer the trials, so I will work on my clinic to see if SW can provide some tix for me and other patients that way...