Cross labeling guidance is in response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens. The purpose of this guidance is to describe FDA’s current recommendations about including relevant information in labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling of these drugs. This guidance does not address all issues that might arise relating to labeling for oncology drugs for use in a combination regimen. Applicants proposing cross labeling for oncology drug combination regimens should contact the review division for information on cross labeling of their individual products.
“Oncology drug applications to the FDA often add investigational drugs to current regimens to create new combination regimens with greater efficacy or safety,” said Richard Pazdur, MD, director of FDA’s Center of Oncology Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research.
In a press statement, Pazdur added, “Sponsors have traditionally not requested cross-labeling—making changes to the labeling of a previously approved drug that describes how to use that drug in a new regimen.” Increasingly, though, Pazdur said that applications are proposing cross-labeling for combinations of drugs to treat cancer.
Accordingly, FDA has laid the groundwork in this guidance for a discussion about how application submissions that involve cross labeling should be handled. In terms of timing, FDA proposes that cross labeling be discussed early in the application process, with labeling for each drug proposed at the same time.
The guidance also proposes considerations and recommendations for the content of labels. The indication should be uniform for all the drugs used in the combination regimen, except that the order and naming format will shift depending on which drug’s label is being considered.
In the dosage and administration section, “in general only the recommended dosage for the applicant’s drug with respect to the combination regiment should be included,” according to the guidance. Clinical study description should be “similar” for all drugs in the cross-labeling regimen.
Warnings and precautions on the labels should include “information unique to the combination regimen, based on synergistic or novel clinically significant adverse reactions and/or risks,” according to the guidance. Adverse reactions should include those observed in the trial that supports approval of the regimen for the sought indication.
Patient counseling information “should be limited to unique toxicities” and preparation and administration considerations relevant to the combination regimen.
Unless there are reasons such as pharmacokinetic considerations for including information about the combination regimen, the remaining sections of the label should only pertain to the applicant’s drug alone.
The Cross labeling draft guidance is open for public comment for a 60-day period. “We are issuing today’s draft guidance to serve as a starting point for discussions between the FDA and sponsors of oncology drugs, as well as the medical and academic communities, and the public on including relevant information in labeling for oncology drugs approved for use in a combination regimen,” said Pazdur.
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