TDM1 EAP - Good news for those in TDM1 EAP study who need to travel

[chrisy]

Just received this information from the Patient Advocate at Genentech. They are working to amend the protocol for the EAP (T-PAS) to allow SOME of the actual treatments to be adminstered locally. They are still not opening any new study sites...but those who, say live in Boston and would have to travel to Fairfax (or in Seattle traveling to So Cal or in Austin going to Denver) may have an option, once they are established in the trial, to get some infusions locally. This is still probably a few months away to get the amendment done and approved.

Still not as good a FDA approval of the drug...but may provide some relief in the interim...

The message she sent me is below:

Genentech has been contacted by multiple patients requesting T-DM1 from their local oncologist as part of T-PAS or seeking individual access. We know that many people have to travel long distances, and we recognize this significant burden, especially considering their advanced cancer. We are trying to do the right thing for patients while ensuring we are being fair, and also not impacting the clinical trials we need to conduct in order to get the medicine approved. Therefore, we are planning to amend the T-PAS protocol, allowing people who are enrolled in the trial and responding to T-DM1 to receive some T-DM1 doses locally. Additional details of the protocol amendment are not yet final, but we are working as quickly as possible and hope to have the amendment in place within 90 days. Our primary goal remains getting T-DM1 approved so access is not an issue for patients.
While we understand it can be difficult and costly to travel long distances, our hope is the amendment alleviates some of the burden by allowing some doses to be administered by a local oncologist. While we are working to get the amendment approved, we recommend people who continue to face travel challenges to contact an organization that may be able to provide travel assistance:


· Air Care Alliance, www.aircareall.org, 888-260-9707
· Air Charity Network, www.aircharitynetwork.org, 877-621-7177
· Airlines of the Web Medical Air Services, www.flyaow.com/airmed.htm
· American Cancer Society (Road to Recovery), www.cancer.org, 800-ACS-2345
· Angel Flight Central, www.angelflightcentral.org, 866-569-9464
· Angel Flight for Cancer Patients, www.angelflightforcancerpatients.org, 800-296-1217
· AVONCares Program, www.cancercare.org, 800-813-HOPE
· CancerCare, www.cancercare.org, 800-813-HOPE
· Chai Lifeline, www.chailifeline.org
· Corporate Angel Network, www.corpangelnetwork.org, 866-328-1313
· Hospitality Homes, www.hosp.org, 888-595-4678
· Joe’s House, www.joeshouse.org, 877-JOESHOU
· Lazarex Cancer Foundation, www.lazarex.org/lookingforhelp.html
· Lifeline Pilots, www.lifelinepilots.org, 800-822-7972
· National Patient Travel Helpline, www.PatientTravel.org, 800-296-1217

[ElaineM]

Thanks !! This is certainly great news for all of us.

[hutchibk]

Yep... I got the email from her just after she sent it to you! This is fantastic new... every little bit helps. My local onc is happy too, that I may not have the expense of traveling so often. I love Genentech.

[chrisy]

Thanks becky or Steph whoever stickied this!

[Chelee]

Hi Chris,
I just replied to this post from you down in clinical trials. lol Didn't know this thread was up here already. It's nice to see someone tacked this up here...it's better suited in the main forum since it's such a hot topic to so many of us.

Thanks Chris for sharing the news. And thanks to whomever moved this to the main board for all to see.

Chelee

[Chelee]

Chris,
Yesterday schoonder posted a message from a blog down in the "Articles of Interest" forum that some might be interested in reading? I hope schoonder doesn't mind me adding it up here? Obviously Genentech is feeling the pressure and being swamped by calls for T-DM1. Here is "schoonder" post below.

--------------------------------------------------------------------------------

Easier access to the drug?
Posted yesterday on assertivecancerpatient blog.
"
'The Straw That Broke the Camel's Back'

Dr. Lee called me at about 1 this afternoon to report on his phone call with Dr. Sandra Horning and Terry Rugg at Genentech.
One thing he said is that he thinks my asking to get T-DM1 on compassionate use was "the straw that broke the camel's back," because Genentech has been hearing from so many women recently who are in my situation: they could be helped by T-DM1, but they can't travel to the nearest clinical trial site.
(Remember, there are only 12 phase II trial sites, and there were supposed to be 20, including one in Seattle at the University of Washington Medical Center--that one never opened.)
I assume that the folks at Genentech were discussing the issue before I came along, otherwise I don't think they could have come up with a solution in 48 hours--which is the amount of time that has passed between Dr. Lee's first phone call with Genentech on Wednesday and today's call.
Not that I'm not delighted to have been that straw, if that was indeed the case. My friends may call me "Straw" now and in the future.
So, this is what they told Dr. Lee:
* Genentech is--or has been--working on a broad program for local delivery. (Translation: I could get T-DM1 at Dr. Lee's office. No more traveling to S. California every three weeks.)
* One piece of this will be demonstrating the drug's safety for the women who get it at their local oncologist's office.
I'm not quite sure what that involves, but proving that the drug is safe for me is a cake walk--I got the drug for seven months with no serious side effects of any kind. Any problems I had during that time were not caused by the T-DM1, except that my platelets did drop, but never low enough that Dr. Ibrahim had to cut my dose. And certainly not low enough to put me in any danger.
Also, let's not forget that I am in remission for the first time in years--five or more, I believe--because of the T-DM1.
* Any hospital or cancer center that wants to offer this to their patients will have to do an IRB. I don't know much about IRBs, except to say that these are review boards within a facility that have to approve the plan. Sometimes this can take time.
* Doctors such as Dr. Lee and their cancer centers or clinics will have to be approved and then the doctors will be added to the trial as principal investigators.
* The FDA will have to approve Genentech's plan.
Next week, let's start lobbying the FDA and also the Congressional committee(s) that oversee the FDA.
* The timeline is about three months.
Now, this is amazing, but what am I supposed to do between now and then? My cancer could come back aggressively within the five months or so since my last T-DM1 treatment and the time this program is up and running.
* Dr. Lee thought of that, and asked about it. The answer: Genentech will allow me to return to the trial in Highland, California, even though I have broken the rules by skipping two (three by now, if not four) treatments.
That is truly amazing!
They did say I would have to get to Highland (Ontario airport) on my own, and they are faxing Dr. Lee a list of organizations that they think might help me financially. I'll get that list from Dr. Lee next week, but how much do you want to bet that I've already contacted most of them? I'm not expecting much help there.
So back to fundraising. Sigh. However, three months is only four treatments/trips, so about $4,000. I think I can raise that much.
I can't begin to say how happy this news makes me. I'm going to have a wonderful summer after all! And my life expectancy is pushed out another year, if not longer.
Thanks, Genentech.
And thanks to Dr. Lee. He put a lot of time into this, and he's going to put in a lot more before we have this plan in place. What can I say? He is the most wonderful doctor.
Read more: T-DM1
Feeling generous? See: My Cancer Travel Fund
@ Jeanne Sather 2011"

[chrisy]

Way to go Jeanne!

And good on genentech, too!

How many "straws" will it take to bend the FDA?

[StephN]

I got your post stickied, Chris.

Think we will need more like cannon balls for the FDA - don't have time to wait for straws to accumulate!

[ElaineM]

Way to go !!!!!!!!!!
If someone is starting a petition I will sign.
I heard about Seattle. My medical group in Hawaii was signing up patients for Seattle, but then found out the whole thing fell apart.

[hutchibk]

I am excited about the possibility, but in reality I am only cautiously optimistic. I won't be devastated if it doesn't come to pass.

From what I understand, it basically takes moving small mountains to make this kind of thing happen. But that doesn't mean it's impossible. Independent/Ethical review boards (and setting them up) is no piece of cake and doesn't happen just because folks click their heels together and wish it so. It seems that for so many different independent clinical docs to be approved to be principal investigators (who aren't already trial docs) will be a bear, but not impossible. I assume they also won't be allowed to accrue, they will only be treating patients who are already on the trial.

And then there's the FDA component. Sigh.

I am not saying it won't happen, I have no way of knowing. I have utmost hope! But I just know it's going to be a difficult journey and as I said, I am cautiously optimistic.

And regardless, I am ready, willing, able and happy to continue to fly to Denver to get my treatments if that turns out to be my only option, until it gets approved.

Best wishes to Genentech for taking this on and trying though! I love them!!

[Adriana Mangus]

Chrisy,

Thank you so much for the news. It's nice to hear you are doing great!!!!!!!

Love,

Adriana

[annfromatlanta]

This is great news, Chrisy! I am participating in the T-DM1 trial in Charleston, SC, traveling there from Atlanta every 3 weeks. Yesterday, I had my first scan after starting the trial. Good news! All tumors had either shrunk or remained stable. I had mixed feelings about the results, because the road trips had been more grueling than I had anticipated they would be when I signed on to the trial. And I was thinking that if the results were not good, that I could get a tried and true, although not as promising treatment AT HOME in Atlanta. But now that I've read your thread, I have hope of soon being able to get the T-DM1 treatments in Atlanta!!!!! I'm thrilled! Thank you so much for posting.

On a side note, for this treatment I was flown, for the first time, by Angel Flight Soars, a local nonprofit that flies patients to treatments all over the Southeast. It was a big improvement to driving.

Ann

[hutchibk]

UPDATE as of today, 9/15/2011, from Genentech:

Genentech would like to provide an update on the protocol amendment to the T-DM1 patient access study (called T-PAS or TDM4884g) that may allow some patients enrolled in the study to receive T-DM1 closer to their homes. We submitted the proposed amendment to the FDA on August 8, 2011, and have received no questions or concerns to date that would require re-evaluation or revision. As a result, we are proceeding with this amendment. All of the study sites involved have been informed, and the next step is for each site to approve and implement it within their own institutions.

The T-PAS protocol amendment provides T-PAS patients the option to enroll into another, ongoing Genentech/Roche study (called the “extension study” or TDM4529g), which, in essence, doubles the number of sites and locations where T-PAS patients can receive T-DM1.. This option is only available to patients currently enrolled in T-PAS. Transferring to one of the extension study sites is optional and available to patients who have completed at least six cycles (18 weeks) of treatment, are determined stable by their doctor (i.e., not progressing and tolerating T-DM1 without major side effects) and meet other required criteria for the TDM4529g study. Current T-PAS patients interested in receiving T-DM1 at a site closer to home should contact the T-PAS study coordinator at their current site. The study coordinator can help determine if one of the extension study sites is closer and begin the transfer process to the new site. Since the amendment requires IRB approval at each of the original T-PAS and extension study sites, some sites may be able to accommodate the transfer of T-PAS patients more quickly than others.

People not enrolled in T-PAS but still interested in T-DM1 should talk to their doctor about their eligibility for the other T-DM1 studies currently enrolling patients.

[norkdo]

Am attempting to look up terms for Criteria. Have footnoted each of below terms. hope the microsoft word footnoting program translates here as cut and paste. if it doesn't i will post the terms next post.
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

[norkdo]

1. The anthracyclines include daunorubicin (Cerubidine), doxorubicin (Adriamycin, Rubex), epirubicin (Ellence, Pharmorubicin), and idarubicin (Idamycin).

2. Taxanes include paclitaxel (Taxol) and docetaxel (Taxotere). Paclitaxel was originally derived from the Pacific yew tree.

3. capecitabine: used in combination with docetaxel, after failure of anthracycline-based treatment. Also as monotherapy, if the patient has failed paclitaxel-based treatment, and if anthracycline-based treatment has either failed or cannot be continued for other reasons (i.e., the patient has already received the maximum lifetime dose of an anthracycline).

4. Fluorouracil (5-FU or f5U) (sold under the brand names Adrucil, Carac, Efudix, Efudex and Fluoroplex) is a drug that is a pyrimidine analog which is used in the treatment of cancer. It is a suicide inhibitor and works through irreversible inhibition of thymidylate synthase.

5. trastuzumab: also known as Herceptin

6. lapatinib: also known as Tykerb It has been approved as front-line therapy in triple positive breast cancer and as an adjuvant therapy when patients have progressed on Herceptin.[3]

[woxycarrie]

I'm meeting a specialist in Indianapolis tomorrow to discuss my candidacy for this TDM-1. Has anyone here been on this?

[phil]

My wife, Lorraine, is doing great on it, just started her 17th month. You can see her on youtube ' FDA Blocks Life -Saving Cancer Drug ", Part 4. ( google the petition by the same title, sign and pass on ). While there , take a look at peter in Part 3. hes doing great on the pertuzumab/t dm-1/taxol trial. Where evryone gets t dm-1 . The next best trial is Theresa, becuase 2 out of 3 get t dm-1. The other trials are 50/50 .
If your cancer strongly overexpresses her 2, t dm-1 seems to work better. My wifes FISH Scale measurement of her2 was a 6.0, anything over 3.0 is considered significant.
There is a s/e of platelet drops. my wifes did, and she took a dose reduction from 3.6 to 3.0. Probably should have done it sooner . Her plats barely stabilized in time to stay in the Study. She got 7 doses at 3.6, now has had 11 at 3.0. Hinsight , maybe 4 -5 doses at 3.6 then dropping to 3.0.
We have not been afraid to speak up, to both Gen. top brass, our Partners Health care Insurers, FDA, Congress. pressure put on us to drop to the lowest dose , 2.4 , by Gen. top brass, even by our own doc, who we love, she had never used it, was nervous , . We refused , its Lorraines life, and we want the strongest dose , until its approved, becuase of the rules. We wrer right ! with 3.0 every 3 weeks, plats slowly stabilized at 65,000 -80,000, slowly rising . And most importantly , the cancer shrunk away. No sign of it on CT's since November !
Another consequence of This FDAs' bureaucratic, political , denial of approval , is that pts continue to be forced into trials with rigid dosing rules ( once you reduce you cant go back up ), and timing ( more than 6 weeks betw. doses, and you may get dropped ). So the s/e of platelet drop is made worse by This FDA ! I know this may sound scary, but want people to be informed. It is a great , breakthrough Drug for metastatic her2 . !! QOL is awesome ! Good luck !

[woxycarrie]

Thanks for the info, Phil. Do you have a link? I can't find it on youtube!

[phil]

Try http://www.youtube.com/watch?v=JlsrTqwUL6g
I google : " FDA Blocks Life -Saving Cancer Drug Rally "

[Emy]

How do you get on trials? I was on Herceptin for 9 months now stopped working...Tumor markers rapidly rising 86 now..started tykerb 1500 with Herceptin, not working..PET scan proved everything doubled in size.....