Drugs

Clarification Sought in Oncology Trial Inclusion Guidance

The Biotechnology Industry Organization (BIO) is asking FDA to clarify how its draft guidance on considerations for inclusion of adolescent patients in adult oncology clinical trials relates to provisions in the Pediatric Research Equity Act (PREA) and the FDA Reauthorization Act of 2017. The association’s comment letter says that if a sponsor enrolls adolescents in an adult trial according to the principles in the draft guidance, the guidance should be revised to describe whether and when the PREA requirements for the adolescent age have been satisfied.

BIO also asks FDA to consider including case examples in the final guidance demonstrating circumstances when adolescents have different physiology and/or psychology, relative to adults.

In its letter, Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the draft guidance and believes that additional adolescent representation in adult oncology clinical trials “will support more robust drug development and help promote public health.” The association also notes that it is important to consider finding ways to encourage inclusion of adolescents in drug development across other therapeutic areas. “The recommendations in this draft guidance could help provide a pragmatic solution for numerous other medical conditions across the therapeutic spectrum, particularly where the relevant disease is severe and life-threatening,” PhRMA says. “With appropriate input from interested stakeholders, FDA could consider extending these recommendations beyond oncology.”

In its letter, AstraZeneca says it is not clear from the guidance if the early enrollment of adolescents will mean that a sponsor has met the agency’s pediatric study requirements under PREA. The company also asks for more guidance on how the draft will interplay with European pediatric regulation, and asks for more information on 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.

Finally, GlaxoSmithKline says it generally agrees with the comments submitted by BIO and PhRMA and then offers some line-by-line specific comments of its own.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome