Drugs

More Study of Patient-Reported Frailty Needed: FDA

CDER researchers say more study is needed to assess the association between frailty, as measured by the Patient-Reported Frailty Phenotype they developed, and clinical outcomes in multiple myeloma. Further work also is needed to compare this phenotype with other frailty measures, they say in an agency online post

“Given the findings in the study,” the post says, “researchers believe there may be more opportunities to use patient-reported data to detect frailty in oncology settings.”

The FDA and outside researchers wanted to know whether patient responses to select questions within the European Organization for Research and Treatment of Cancer Quality of Life 30-item questionnaire could be used as a proxy for the Fried Frailty Phenotype to assess frailty in patients with multiple myeloma.

They looked at records of 4,928 patients who participated in nine multiple myeloma treatment trials between 2010 and 2021, and chose five questionnaire items that measured the same or similar concepts to each Fried Frailty criterion. The researchers’ classification of the patients as fit (55.4%), pre-frail (24.5%), or frail (20.1%) based on the five-item questionnaire they developed tracked with findings in a prior prospective study of patients with relapsed/refractory multiple myeloma as determined by the International Myeloma Working Group frailty index.

The researchers say they believe this is one of the first studies to research a fully patient-reported frailty model in the context of multiple myeloma. “Given patients’ first-hand experience with the disease, they are often able to self-report frailty symptoms,” the report says. “However, this type of scientific information is often underutilized when measuring frailty in oncology. Multiple studies in the general non-cancer older adult population have shown the value of patient-reported frailty measures…. Creating a more validated questionnaire would likely require more extensive feedback from patients and experts in different scientific disciplines.”

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