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# Comments on Cross Labeling Oncology Drugs Guidance
- URL: https://www.fdaweb.com/comments-on-cross-labeling-oncology-drugs-guidance/
- Published: 2021-01-26T12:00:00.000Z
- Updated: 2026-09-14T16:44:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148521

Merck says an FDA draft guidance, *Cross Labeling Oncology Drugs in Combination Regimens*, is needed, given the increasing importance of oncology combination regimens for optimal patient treatment. “The guidance is informative, but does not include much information on acceptable trial design, except for a brief mention of FDA’s support for the use of historical data (pragmatic trials),” the company [comment letter](https://beta.regulations.gov/comment/FDA-2020-D-2107-0004?ref=fdaweb.com) says. The letter reviews the ways that oncology drugs may be studied in combination and says the draft seems to focus on combination regimens that involve two unapproved drugs, with a brief mention of adding drugs to a current regimen. “Thus,” it says, “it is not entirely clear whether the guidance would apply to other types of combinations. It would be helpful if FDA were to provide clarity on whether all potential oncology combinations are subject to this guidance or only those that involve two or more investigational agents or adding a drug (unapproved or approved — for any indication) to an existing regimen.

Merck also asks FDA to clarify how to label the combination regimen for dose changes, discontinuations and interruptions, and adverse events. And it includes specific line-by-line comments.

Alkermes [says](https://beta.regulations.gov/comment/FDA-2020-D-2107-0006?ref=fdaweb.com) it finds the guidance helpful in many respects and identifies areas that it says warrant further consideration at the agency finalizes the document.

[GlaxoSmithKline](https://beta.regulations.gov/comment/FDA-2020-D-2107-0002?ref=fdaweb.com) and [Pfizer](https://beta.regulations.gov/comment/FDA-2020-D-2107-0003?ref=fdaweb.com) each submitted specific line-by-line comments.