The ACPM advised that implementation by the sponsor of the recommendations outlined above to the satisfaction of the TGA, in addition to the evidence of efficacy and safety provided would support the safe and effective use of this product. Outcome on a review of quality, safety and efficacy, TGA approved the registration of Keytruda pembrolizumab (rch) 50 mg powder for injection vial indicated for: Keytruda (pembrolizumab (rch)) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults. Specific conditions of registration applying to these goods Keytruda European Risk Management Plan (version 1.1, dated 9 February 2015) with Australian Specific Annex, dated August 2014 and revised to the satisfaction of the TGA, or any updates to these documents that are agreed by the TGA, must be implemented. It is a condition of registration that, as a minimum, the first five independent batches of Keytruda pembrolizumab (rch) 50 mg vial imported into in Australia are not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories Branch (LB). Attachment 1. Product Information The PI for Keytruda approved with the submission is described in this AusPAR is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
The ACPM advised that implementation by the sponsor of the recommendations outlined above to the satisfaction of the TGA, in addition to the evidence of efficacy and safety provided would support the safe and effective use of this product. Outcome on a review of quality, safety and efficacy, TGA approved the registration of Keytruda pembrolizumab (rch) 50 mg powder for injection vial indicated for: Keytruda (pembrolizumab (rch)) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults. Specific conditions of registration applying to these goods Keytruda European Risk Management Plan (version 1.1, dated 9 February 2015) with Australian Specific Annex, dated August 2014 and revised to the satisfaction of the TGA, or any updates to these documents that are agreed by the TGA, must be implemented. It is a condition of registration that, as a minimum, the first five independent batches of Keytruda pembrolizumab (rch) 50 mg vial imported into in Australia are not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories Branch (LB). Attachment 1. Product Information The PI for Keytruda approved with the submission is described in this AusPAR is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
auspar-pembrolizumab-rch-161014.docx