KADCYLA ( TDM1 ) APPROVED BY EU FOR HER2 POSITIVE BREAST CANCER

dfd24
dfd24 Member Posts: 91
in Esophageal Cancer #1

KADCYLA APPROVED BY EU FOR HER2 POSITIVE BREAST CANCER




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Started by daniele about 12 hours ago


also considered for EC

"Kadcyla has been approved for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin(R) (trastuzumab) and a taxane, separately or in combination. Patients should have either: (1) received prior therapy for locally advanced or metastatic disease or (2) developed disease recurrence during or within six months of completing adjuvant therapy.

As with the Kadcyla approvals that have been granted in the US, Japan, and other geographies, the approval in the EU is based on the findings in the EMILIA Phase III trial. In the EU and other international markets, the timing of the commercial availability of Kadcyla after approval can vary due to national differences in processes for establishing pricing/reimbursement, with some countries - including Germany - able to launch shortly after approval."

http://www.marketwatch.com/story/immunogen-inc-announces-approval-of-roches-kadcylar-in-the-european-union-2013-11-20?reflink=MWnewsstmp



Comments

  • goty2001
    goty2001 Member Posts: 71
    #2
    TDM1

    Thanks. Good News

  • callerid
    callerid Member Posts: 96
    #3
    KADLYCA T-DM1

    My husband was denied T-DM1 by the insurance company as it was not considered standard of care for EC.  So he applied to the manufacturer but was denied based apparently on the code his oncologist put on the application. So our only choice is to go ahead with T-DM1 infusion, submit it to insurance, which they will deny, then be billed for it personally. It's cost is around $18,000 per infusion. 

    I have not found a whole lot of supportive data on the success of this drug either in breast or esophageal.  I only know his primary oncologist has said he has seen some promising results. The oncologist where he gets his infusions, told him all these new treatments only add about three extra months.  He believes in hospice.

     

     

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