HER2 Support Group Forums - View Single Post - Compassionate Use Criteria for T-DM1 by Roche

HopeAbides · 12-09-2012, 06:59 AM

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.

12-09-2012, 06:59 AM	#1
HopeAbides Member Join Date: Nov 2012 Posts: 8	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.