Biotech Values

[rfj1862]

Irinotecan news

Another blow to Pfizer?

Many physicians won't bother genotyping their advanced CRC patients and just use oxaliplatin first-line. A shame, because in my view irinotecan is inherently superior to oxaliplatin in the metastatic CRC setting--not to mention the evidence base is better for irinotecan plus targeted agents compared with oxaliplatin plus targeted agents.

John





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FDAAdvisoryCommittee.com News Alert - October 20, 2005
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NEW TODAY on FDAAdvisoryCommittee.com

http://www.FDAAdvisoryCommittee.com


>>> Pharmacogenetic Data Integration Into Product Labeling To Be Discussed At Meeting



Translation of pharmacogenetic information into label updates will be discussed by FDA’s Clinical Pharmacology Subcommittee during a Nov. 14-15 meeting.

The agency is asking the subcommittee of the Advisory Committee for Pharmaceutical Science to “discuss and provide comments on the evidence and process for translation of pharmacogenetic information (e.g., cytochrome P 2C9 polymorphisms) into label updates for approved products.”

The issue has been of particular interest with regard to oncology agents, many of which have well-known toxicities. Genotyping patients according to metabolizing enzymes, for example, could become a primary tool in selecting the least toxic therapies for specific patients.

During the clin-pharm subcommittee’s previous two-day meeting in November 2004, the pharmacogenetic toxicity risk of Pfizer’s oncologic Camptosar (irinotecan) was discussed as an example of information to be included in the agent’s labeling.

The group voted nine to zero with three abstentions in favor of genotyping patients to find those deficient in an irinotecan metabolizing enzyme.

FDA cleared an sNDA in June to update Camptosar’s labeling to recommend a lower starting dose for such patients.

Discussion of FDA’s “Critical Path” initiative will occur on both days of the meeting. On Nov. 14, discussion will focus on “end-of-Phase IIa meetings which will include a case study.”

FDA has been pursuing the addition of a pharmacometrics branch to CDER’s Office of Clinical Pharmacology and Biopharmaceutics. As part of that effort, a pharmacometrics team has been involved in EOP2A meetings with sponsors.

On Nov. 15, the subcommittee will discuss several critical path-related topics: “the use of biomarker information in labels to facilitate individualizing pharmacotherapy”; “the analytical and clinical validation criteria for approving a clinical assay”; and “an update on the critical path biomarker-surrogate endpoint project.”

The group initially discussed the transition of biomarkers to surrogate endpoints during the November 2004 meeting. Part of the project includes a biomarker working group tasked with developing a guidance.

As part of its effort to encourage biomarker qualification, FDA is prepared to issue guidances on specific biomarkers, Deputy Commissioner of Operations Janet Woodcock said Oct. 6 at a Drug Information Association conference.

The clin-pharm subcommittee is also slated to discuss “current evidence related to the pharmacogenetics of warfarin as a potential basis for label updates.”