Qualifying Notice Amendment - Vectibix
Biologics and Genetic Therapies Directorate
200 Tunney's Pasture Driveway
Address Locator #0701A
File #: 9427-A0969\5-23
July 10, 2008
[Employee's name removed]
Manager, Regulatory Affairs
Amgen Canada Incorporated
6775 Financial Drive, Suite 100
Amendment To Notice Of Compliance With Conditions Qualifying Notice
Dear [Employee's name removed]:
Further to the February 22, 2008, Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN) issued for your New Drug Submission for Vectibix (panitumumab), Control # 105601, and the Letter of Undertaking dated April 2, 2008, submitted by Amgen Canada Inc. in response to the NOC/c-QN, the Biologic and Genetic Therapies Directorate (BGTD) has reconsidered commitment 2c in the NOC/c-QN that reads as follows:
"ensure that the KRAS testing kit is available in Canada before launching the product."
In light of the sufficient labelling of this drug that itself takes account of evolving medical knowledge on the use of antineoplatic medications in patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS, commitment 2c has been determined not be applicable in these circumstances.
Note that the Vectibix labelling remains unchanged as a result of this amendment to the NOC/c-QN.
While, for this reason Amgen's adherence to this commitment will not be assessed in relation to the NOC/c policy it must be emphasized that a KRAS testing kit is considered an in vitro diagnostic device under the Medical Device Regulation. As such, the BGTD recommends that Amgen Canada Inc. contact the Medical Devices Bureau of the Therapeutic Products Directorate for regulatory guidance regarding the filing of a submission for a KRAS testing kit in the detection of non-mutated KRAS expression.
original signed by
Dr. Elwyn Griffiths
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