Biopharma Firms: Make FDA Draft Guidance on Including Adolescents in Adult Oncology Trials Global

Regulatory NewsRegulatory News | 07 August 2018 |  By 

AstraZeneca, Gilead, GlaxoSmithKline and lobbying groups PhRMA and BIO are calling for further global harmonization of a US Food and Drug Administration (FDA) draft guidance on including adolescents in adult oncology clinical trials.

Industry group BIO said that because the draft, released in June, “signals the first time that a health authority memorializes the principles outlined in the Guidance (i.e., recommendation to enroll adolescents in adult oncology studies), we ask the FDA to consider reviewing and discussing the Draft Guidance with other global health authorities at upcoming pediatric cluster calls.”

PhRMA also suggests that FDA engage with Investigational Review Boards (IRBs) “to ensure that they are aware of this guidance.”

GSK, meanwhile, said it “welcomes the initiative for harmonization between global health agencies to align on accelerating the development of oncology therapies for adolescents whenever possible.”

Similarly, AstraZeneca called for more guidance on how this draft would interplay with the European pediatric regulation, including expectations and alignment.

“It may be helpful if the Agency can provide more information regarding the minimal number of adolescents that may be required and any learnings that the Agency has applied from other therapeutic areas that already include adolescents in adult trials (e.g., asthma) would be appreciated,” AstraZeneca added.

PhRMA also recommended that FDA confirm that studies enrolling adolescent patients in adult oncology trials would be considered sufficient to meet Pediatric Research Equity Act requirements.

Memorial Sloan Kettering Cancer Center (MSKCC) also raised some concerns with the draft, particularly with the statement in the draft that “adolescents may be enrolled after initial adult PK and toxicity data are obtained.”

MSKCC said this statement “is too vague and may well discourage the enrollment of adolescents in Phase I adult oncology trials. While we believe that the aim of the guidance is to promote the enrollment of adolescent patients at all phases of drug development, MSK strongly encourages the FDA to clarify what is meant by the phrase ‘initial adult PK and toxicity data.’”



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