May 17, 2024 - FDA Roundup: May 17, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The prescribing information for tarlatamab-dlle includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). The most common adverse reactions (>20%) were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea. Full prescribing information for Imdelltra will be posted here.
• On Thursday, the FDA announced the qualification of a patient-reported outcome instrument through the Medical Device Development Tools program, to assess frequency and bother of ocular symptoms in certain patients after receiving bilateral intraocular lens implants. The instrument can help quantify and provide patients and clinicians with information regarding visual symptoms and it assesses symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses.  
• On Thursday, the FDA provided an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China. Specifically, the FDA announced an import alert for Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd. for not meeting device quality system requirements, to prevent plastic syringes made by these China-based manufacturers from entering the U.S. Additionally, the FDA recommendations have been updated to include that users should also immediately transition away from using plastic syringes made by these manufacturers, unless use of these syringes is absolutely necessary until the transition to syringes that are not manufactured in China is complete.
• On Wednesday, the FDA posted on its website its determination that tara flour in human food does not meet the Generally Recognized As Safe (or GRAS) standard and is an unapproved food additive. The FDA’s assessment of the ingredient is detailed in a memo added to the agency’s public inventory. Increased transparency of our assessment of ingredients in the food supply is part of our approach to enhance food chemical safety.
• On Wednesday, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The most common nonlaboratory adverse reactions (≥20%) were cytokine release syndrome (CRS), headache, musculoskeletal pain, fatigue, constipation, and fever. The FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy due to the risk of fatal or life-threatening CRS and neurologic toxicities. Full prescribing information for Breyanzi will be posted here.
• On Wednesday, the FDA published the FDA Voices: “Protecting and Advancing the Health of Women Through Policy, Research, Education and Outreach,” by Robert M. Califf, M.D., Commissioner of Food and Drugs and Kaveeta P. Vasisht, M.D., PharmD, Associate Commissioner for Women’s Health and Director of the Office of Women’s Health. Thirty years ago, the FDA’s Office of Women’s Health (OWH) was established to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women. Since its inception in 1994, OWH has been at the forefront of ensuring that the unique health needs of women are prioritized through a multifaceted approach that encompasses policy, research, education, and outreach.
• On Wednesday, the FDA announced a webinar: Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances that will be held on Wednesday, June 5, 2024, from 1-2 p.m. ET. During the webinar, the FDA will provide an overview of two draft guidances and provide responses to previously submitted questions. If you have questions about the draft guidances that you wish to submit for possible discussion during the webinar, please email [email protected]. All questions must be received by May 24, 2024, to be considered for the discussion. Questions will not be taken during the live webinar. Registration is not required.  
• On Tuesday, the FDA approved expansions to the indications for use (IFU) of the Beckon, Dickinson (BD) and Co. Onclarity HPV Assay and the Roche Molecular Systems, Inc. cobas HPV Test. These tests were each previously approved (P160037, P100020, and P190028, respectively) for cervical cancer screening through the detection of Human Papillomavirus (HPV) in cervical specimens collected in a health care setting by a clinician. The expanded IFUs allow for the patient to self-collect a vaginal swab in a health care setting when the patient and the health care provider determine that it is not possible for the clinician to collect a cervical specimen. The approvals for use of self-collected vaginal specimens with these HPV tests are the latest example of the FDA’s continued commitment to expanding cervical cancer screening options for patients, particularly for individuals currently not participating/engaging in routine screening.

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