Drugs

Broader Use for Pediatric Cancer Trial Eligibility: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says that a draft guidance on “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients” should be applicable across other therapeutic areas, as appropriate. In comments on the guidance, PhRMA says it believes that the considerations for inclusion of pediatric patients in adult clinical trials outlined in the draft guidance are relevant beyond oncology products. “Further, the recommendations in this draft guidance could help provide a pragmatic solution for numerous medical conditions across the therapeutic spectrum, particularly where the relevant disease or condition is serious or life-threatening,” the group says.

PhRMA’s comments addressed FDA’s recommendation on modeling and simulation used to understand potential differences in pharmacokinetic (PK) and pharmacodynamic (PD) as well as dose selection. “As this wording can be potentially interpreted as limiting in its intent, PhRMA recommends that the discussion of modeling and simulation be addressed in greater detail in a separate section of this draft guidance as these methods are relevant in both preclinical and clinical contexts,” according to the comments. “Data from clinical and nonclinical contexts can be used to understand PK/PD and can support extrapolation. PhRMA also believes that real-world data (RWD) and real-world evidence (RWE) can provide supportive evidence for the inclusion of children in adult oncology clinical trials.” PhRMA also recommends that any final guidance include a discussion of RWD/RWE as a form of evidence that may support including pediatric patients in adult oncology trials.

Additionally, PhRMA seeks clearer recommendations on pediatric starting doses. The group recommends that the guidance indicate that “clinical and nonclinical data can be used to determine the safe starting dose in children. Modeling and simulation approaches, including extrapolation, can also be used to determine the starting dose. Although the starting dose in children is typically lower than in adults, PhRMA believes that consideration should be taken to determine the safe and efficacious dose (e.g., if pediatric patients experience similar exposure response as adults).”

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

Read more

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