Compassionate Use Criteria for T-DM1 by Roche
 

Hi All,

I've worked really hard to get the exact criteria for compassionate use of T-DM1.

As most of you know, T-DM1 is under FDA approval process and may available in the market by Feb 2013, if everything goes fine.

For anyone who would still need T-DM1, being unable to participate in clinical trials, here is the info I got, direct from the company - This is the compassionate use clause where a drug can be provided even before the FDA approval.

Hope it helps.

Roche is providing T-DM1 on compassionate basis for patients who have exhausted all possible current options of treatment.
Following is the eligibility criteria for Compassionate Use of T-DM1 in HER2 positive metastatic breast cancer patient. The patient:
• Does not participate currently in any clinical trial
• Has received at least two lines of trastuzumab (herceptin) containing regimens with two different chemo backbones(*) for their metastatic disease(TML)
• Has received in addition at least one line of Lapatinib for their metastatic disease
• Patients must have documented recent progression on last treatment
• Patient must be able to tolerate the Compassionate use of T-DM1 therapy
(*) Anthracyclines, taxanes and capecitabine must have been used for their metastatic disease, unless medical reasons preclude the administration of one or more of the above agents.

Re: Compassionate Use Criteria for T-DM1 by Roche
 

Thank you, HopeAbides.

We have been posting the T-PAS (T-DM1 pre-FDA approval) sites that have been opening all over the country this past year.

It is good to have the inclusion criteria here, as well.

Check under the Clinical Trials & HER2 Group Forums here for "Stickys" at the top of the treads for those sites.

Re: Compassionate Use Criteria for T-DM1 by Roche
 

Thank you for posting this for all of us.

Re: Compassionate Use Criteria for T-DM1 by Roche
 

Hi All,

Just wanted to know if there is any recent progress on T-DM1 approval by FDA. Waiting with bated breath as there are no clinical trials available in India till now.

Anyone with any leads will surely be of much help. They are saying January, but that could be delayed.

Thanks