A.) The sponsor should recommended. Of add a statement in the PI relevance the sponsor describing that the states in their response: product has been it was recommended that derived mammalian the patient’s active cells of Hamster origin. infection be treated prior B.) The sponsor should to the start of therapy add a statement with pembrolizumab in informing health care study P001. professionals that As such a patients with active recommendation was infections should be made during the clinical appropriately treated development program, prior to commencement and there is no safety of therapy with data available for Keytruda. C.) The patients being treated sponsor should amend with an active infection, the PI to include a this recommendation to statement describing the Delegate remains. that only experienced C.) The sponsor has oncologists should added the following administer the product. statement: Treatment In regard to the must be initiated and proposed routine risk supervised by healthcare minimisation activities, professionals experienced it is recommended to the in the treatment of Delegate that the draft cancer. CMI document be It is recommended to the revised as follows: Delegate that this D.) The sponsor should statement be amended add a statement in the to: Treatment must be CMI informing patients initiated and supervised with a known allergy to by specialist physicians Hamster protein to be experienced in the more cautious when treatment of cancer. receiving Keytruda. D.) The sponsor has not included a statement as recommended. This recommendation remains. Summary of recommendations Outstanding issues RMP related issues remaining from the round 1 RMP report The sponsor should provide justification as to why disorders’ was added as ‘Skin potential risk rather than an identified risk to the table of ongoing safety concerns. It is recommended that in patients with an active infection’ be added as ‘Safety missing information to the table of ongoing safety concerns.
A.) The sponsor should add a statement in the PI describing that the product has been derived mammalian cells of Hamster origin. B.) The sponsor should add a statement informing health care professionals that patients with active infections should be appropriately treated prior to commencement of therapy with Keytruda. C.) The sponsor should amend the PI to include a statement describing that only experienced oncologists should administer the product. In regard to the proposed routine risk minimisation activities, it is recommended to the Delegate that the draft CMI document be revised as follows: D.) The sponsor should add a statement in the CMI informing patients with a known allergy to Hamster protein to be more cautious when receiving Keytruda. recommended. Of relevance the sponsor states in their response: it was recommended that the patient’s active infection be treated prior to the start of therapy with pembrolizumab in study P001. As such a recommendation was made during the clinical development program, and there is no safety data available for patients being treated with an active infection, this recommendation to the Delegate remains. C.) The sponsor has added the following statement: Treatment must be initiated and supervised by healthcare professionals experienced in the treatment of cancer. It is recommended to the Delegate that this statement be amended to: Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer. D.) The sponsor has not included a statement as recommended. This recommendation remains. Summary of recommendations Outstanding issues RMP related issues remaining from the round 1 RMP report The sponsor should provide justification as to why ‘Skin disorders’ was added as potential risk rather than an identified risk to the table of ongoing safety concerns. It is recommended that ‘Safety in patients with an active infection’ be added as missing information to the table of ongoing safety concerns.
auspar-pembrolizumab-rch-161014.docx