Regulatory Open Forum

We plan to conduct a combination study of our investigational oncology drug X and Merck's Keytruda (pembrolizumab) for pancreatic cancer, which is not an approved indication in Keytruda USPI. We plan to submit a combination IND to FDA. Will FDA require a Letter of Authorization from Merck to be included in the IND since we will reference Keytruda for this unapproved indication  ?

A letter of authorization from Merck would not be required unless you want to rely on information owned by Merck that was not reviewed as part of a marketing authorization application.

Thanks Glen. Is there a provision in any FDA guidance or regulation that you can point me to on this topic ?

I am not aware of a specific regulation or guidance related to IND applications. My concept of this is based on the regulations and guidance related to 505(b)(2) NDA applications where it is pretty well defined how a product that relies on FDA review of an approved product is addressed. Such an application only requires new investigations for changes from the reference listed drug. In the case of an approved drug, FDA has already concluded that it is safe and effective for the approved indication and the manufactured product meets quality requirements. If you were using the Keytruda as approved and off the shelf, you wouldn't need a letter of authorization. Use for a new indication would only require information that supports the use of the drug for that indication, which I presume your company would own or has access to in literature. My additional comment was related to knowledge you may have regarding data Merck has that is not part of the approval package or in the public domain.