Good News - TDM-1

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orange1
orange1 Member Posts: 930
edited June 2014 in HER2+ (Positive) Breast Cancer

From a drug industry newsletter.  T-DM1 should be available to Stage IV women sooner than originally anticipated.  Keep in mind that the 33% objective response rate is in women who have had multiple previous chemo regimens.  In women with fewer previous chemo regimens, objective response rate tends to be much higher.

Roche has accelerated the expected U.S .filing date for its next-generation breast cancer product, trastuzumab-DM1 (T-DM1), CEO Severin Schwan told an April 15 earnings call. The expedited submission, which will now take place this year, will be based on Phase II data.

FDA has given a green light to the move, and the timing of the NDA submission for T-DM1 was advanced after discussions with the agency. The basis for the move is strong Phase II data in women who had not responded to previous treatments, Schwan said.

FDA's accelerated approval pathway allows sponsors to submit drugs for life-threatening conditions for approval based on strong early data, with requirements to confirm the findings in full Phase III studies in the post-market setting.

The T-DM1 Phase II data were presented at the San Antonio Breast Cancer Symposium last December, and analysts subsequently began predicting that an NDA filing might come this year, instead of in 2012, as originally planned by Roche.

The Phase II study, which took place in 110 women with HER-2 positive metastatic breast cancer, found that T-DM1 was associated with a 33 percent objective response rate when given as a third-line therapy. There were no new or unexpected side-effects.

 
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  • mthomp2020
    mthomp2020 Member Posts: 1,959
    edited April 2010

    This is really good news.  I've been keeping my fingers crossed for this being approved sooner rather then later.  I'm prone to neuropathy, so a new drug that doesn't cause it is a huge plus for someone like me!

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  • waterlady
    waterlady Member Posts: 56
    edited April 2010

    I am on this trial, but receiving Taxotere and Herceptin instead of the trial drug.  If I progress, I will be switched to T-DM1.  The side effects that I am aware of, from those on the trial, is a drop in platelets.

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  • chainsawz
    chainsawz Member Posts: 3,473
    edited April 2010

    Yay!!   I am on herceptin and tykerb......I am so happy to have another option in the wings!!! 

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  • helena67
    helena67 Member Posts: 357
    edited April 2010

    That IS good news, Orange. Finally we are getting some speediness. We should get away from the old school that everything takes 20 years to get approval and another 10 to figure out which patients get the most benefit.

    I saw some other news flash recently - don't remember where - of a planned study where they tailor treatment based on genetic markers.

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