FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations
FDA finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV.
DETAILS: The U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.
This updated policy is based on the best available scientific evidence and is in line with policies in place in countries like the United Kingdom and Canada. It will potentially expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.
These final recommendations are consistent with the policy initially proposed in January. The FDA worked diligently to review and consider all comments submitted to the agency to finalize these recommendations as quickly as possible. "The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community," said Peter Marks, M.D., PhD., director of the FDA’s Center for Biologics Evaluation and Research. "The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place."
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This policy eliminates time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Under the final guidance issued today, all prospective blood donors will answer a series of individual, risk-based questions to determine eligibility. All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.
Additionally, under these final recommendations, those taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)), will also be deferred. Though these antiretroviral drugs are safe, effective, and an important public health tool, the available data demonstrate that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results. Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact. As stated in the guidance, individuals should not stop taking their prescribed medications, including PrEP, or PEP, in order to donate blood. The FDA remains committed to evaluating additional data and new technological developments as they become available to inform our donor eligibility recommendations.
The FDA has been evaluating alternatives to time-based deferrals for MSM and helping to facilitate the generation of scientific evidence that would support an individual risk based- assessment blood donor questionnaire. This scientific information has given the agency a solid foundation to support this new policy. The FDA strongly believes the implementation of an individual risk-based approach will not adversely affect the safety or availability of the U.S. blood supply.
The FDA carefully reviewed numerous data sources, including data from countries with similar HIV epidemiology that have implemented an individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, performance characteristics of nucleic acid testing for HIV and the FDA-funded Assessing Donor Variability And New Concepts in Eligibility study. The ADVANCE study examined the rates of HIV risk factors, such as anal sex and rates of HIV infection, as well as the usage of medications to treat or prevent HIV infection, among MSM study participants.
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Source: FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations. FDA. Published: May 11, 2023.
FDA Approves Engineered Viral Immunotherapy for Treatment-Resistant Advanced Melanoma
FDA approved Tudriqev, an engineered HSV-1-based viral immunotherapy, for adults with treatment-resistant advanced melanoma. The therapy produced tumor responses in 24.2% of patients with a median response duration of 14.1 months. Ongoing Phase III evaluation will further assess long-term efficacy and safety.
KEY FINDINGS: FDA approval of Tudriqev introduces an engineered viral immunotherapy option for adults with treatment-resistant advanced melanoma. By combining direct tumor destruction with immune activation, this therapeutic approach expands the available immunotherapy landscape for patients with limited options after progression on standard treatments. Continued evaluation through confirmatory studies will determine its long-term clinical role in melanoma management.
BACKGROUND: Patients with advanced melanoma whose disease progresses despite available systemic therapies have limited treatment options and significant unmet clinical needs. The U.S. Food and Drug Administration (FDA) approved a new engineered viral immunotherapy designed to provide a treatment option for adults with advanced melanoma that is resistant to prior therapies.
DETAILS: The FDA approved Tudriqev (vusolimogene oderparepvec, formerly RP1), an engineered oncolytic viral immunotherapy developed by Replimune, for adults with unresectable or metastatic melanoma that has progressed following treatment with an anti–PD-1 therapy and, when appropriate, targeted therapy for BRAF-mutated disease. Tudriqev is an engineered herpes simplex virus type 1 (HSV-1)-based therapy administered through intratumoral injection. The treatment is designed to selectively replicate within tumor cells, promote tumor cell destruction, and stimulate an immune response against cancer cells. The FDA approval was based on clinical evidence demonstrating tumor responses in patients with advanced melanoma who had limited therapeutic alternatives. The therapy represents an additional immunotherapeutic approach that uses direct tumor targeting combined with immune system activation. In clinical evaluation, Tudriqev demonstrated tumor reduction or elimination in 24.2% of treated patients, with a median duration of response of 14.1 months. The FDA approval provides a new treatment option for patients with advanced melanoma whose disease has become resistant to prior immunotherapy approaches. A confirmatory Phase III study is ongoing to further evaluate the therapy’s clinical benefit and long-term outcomes.
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Gut Microbiome Dysbiosis Promotes Breast Cancer Dissemination Through Altered Bile Acid Signaling
Gut microbiome dysbiosis increases primary bile acids, triggering mammary inflammation and promoting HR+ breast tumor dissemination through PGE2 signaling. Bile acid, insulin resistance, and PGE2 gene signatures were associated with reduced survival, while bile acid sequestrant use correlated with longer restricted mean survival time in metastatic disease.
KEY FINDINGS: This study demonstrates that gut microbiome imbalance may contribute to HR+ breast cancer progression through systemic metabolic and inflammatory mechanisms. Dysbiosis-associated elevation of primary bile acids was shown to promote mammary inflammation and tumor dissemination through PGE2 signaling. Clinical database analyses further suggested that bile acid pathway modulation, including bile acid sequestrant use, may be associated with improved survival outcomes in metastatic disease. These findings highlight the potential importance of microbiome-derived metabolites in cancer biology and future precision oncology strategies.
BACKGROUND: Breast cancer metastasis remains a major clinical challenge, particularly in hormone receptor-positive (HR+) tumors, which represent the most common metastatic breast cancer subtype. Emerging evidence suggests that alterations in the gut microbiome may influence systemic inflammation and cancer progression. This study investigated whether commensal dysbiosis alters bile acid metabolism and contributes to mammary gland inflammation and HR+ breast tumor dissemination.
DETAILS: Researchers evaluated the relationship between gut microbiome alterations, bile acid signaling, inflammation, and breast cancer progression using experimental models and human genomic and clinical datasets. Metabolomic profiling demonstrated increased primary bile acids in dysbiotic microbiomes. Additional mechanistic studies using bile acid sequestration and supplementation approaches examined how altered bile acid levels influenced mammary inflammation and tumor dissemination.
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The investigators further analyzed The Cancer Genome Atlas (TCGA) data to evaluate associations between bile acid-related signatures, insulin resistance, prostaglandin E2 (PGE2) signaling, and survival outcomes in patients with HR+ breast tumors. Electronic health record data from the Epic Cosmos database were also examined to assess associations between bile acid sequestrant use and outcomes among patients with metastatic disease.
Commensal dysbiosis increased primary bile acid levels by disrupting microbial bile acid metabolism. Elevated primary bile acids promoted mammary gland inflammation and enhanced HR+ breast tumor dissemination through a prostaglandin E2 (PGE2)-dependent pathway.
TCGA analysis demonstrated that gene signatures related to bile acids, insulin resistance, and PGE2 signaling were associated with reduced survival in patients with HR+ tumors. In complementary clinical data analysis, bile acid sequestrant use was associated with longer restricted mean survival time among patients with metastatic disease.
These findings identify gut microbiome–bile acid signaling as a potential biological pathway linking intestinal dysbiosis with breast cancer progression and suggest that modulation of bile acid pathways may represent an area for future therapeutic investigation.
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Source: Putelo, A. M., Bajgai, S., Poblete, M. K., et al. Commensal Dysbiosis Alters Primary Bile Acid Signaling to Drive Mammary Gland Inflammation and Breast Tumor Dissemination. Cancer Research. 2026; Published: June 2, 2026. DOI: 10.1158/0008-5472.CAN-25-4466
Obesity, Rather Than High Body Surface Area Alone, Predicts Clinically Significant Asparaginase Toxicity During Induction Therapy for Acute Lymphoblastic Leukemia
Among 4,925 children and young adults with ALL, obesity—not high BSA alone—was the strongest predictor of clinically significant asparaginase toxicity. Patients with obesity and high BSA had the highest risk of hepatic toxicity and thromboembolism, whereas induction toxicities were not associated with increased end-of-induction MRD positivity.
KEY FINDINGS: This large multicenter analysis demonstrates that obesity-not elevated BSA alone-is the principal patient-related risk factor for clinically significant asparaginase toxicity during induction therapy for ALL. The greatest excess risk occurred in patients with both obesity and high BSA, particularly for hepatic toxicity and thromboembolic events, while pancreatitis risk was unaffected. Older age independently increased toxicity risk, especially hyperbilirubinemia. Notably, induction-phase AAT did not compromise early treatment response, as measured by EOI MRD. These findings suggest that obesity should be prioritized when identifying patients for enhanced toxicity surveillance and future preventive strategies, whereas high BSA in the absence of obesity does not appear to justify dose modification based solely on body size.
BACKGROUND: Asparaginase remains a cornerstone of induction therapy for acute lymphoblastic leukemia (ALL), but treatment-limiting toxicities frequently interrupt therapy and may compromise long-term outcomes. Previous studies have produced conflicting evidence regarding whether older age, obesity, or high body surface area (BSA) independently increase the risk of asparaginase-associated toxicities (AAT). This large Children’s Oncology Group analysis evaluated the relative contributions of these risk factors and examined whether induction-phase AAT affected early treatment response measured by end-of-induction (EOI) minimal residual disease (MRD).
DETAILS: This retrospective analysis included 4,925 patients aged 1-30 years enrolled in the Children’s Oncology Group trials AALL0232 and AALL0434. All patients received a single induction dose of pegaspargase 2500 IU/m² without dose capping. Investigators assessed grade >=3 hyperbilirubinemia, grade >=4 alanine aminotransferase (ALT) elevation, grade >=2 thromboembolism, and grade >=3 acute pancreatitis. Multivariable analyses evaluated the independent effects of age, obesity, and BSA, while EOI MRD positivity (>=0.01%) was analyzed to determine whether AAT adversely influenced early leukemia response. Among 4,925 patients, 290 (6%) experienced at least one clinically significant AAT during induction. Toxicity rates increased with advancing age and obesity. After adjustment for confounding variables, obesity independently increased the likelihood of AAT (OR 2.5; 95% CI 1.88-3.24), whereas high BSA alone was not an independent predictor. Patients with both obesity and high BSA had the greatest risk of overall AAT (OR 3.3; 95% CI 2.22-4.77), while high BSA without obesity was not associated with increased risk (OR 1.4; 95% CI 0.94-2.04). Older patients (>=10 years) demonstrated more than a twofold increase in AAT risk compared with younger children.
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Obesity combined with high BSA significantly increased the risk of hyperbilirubinemia (OR 3.5; 95% CI 2.2-5.7), severe ALT elevation (OR 3.3; 95% CI 1.7-6.6), and thromboembolism (OR 3.1; 95% CI 1.5-6.5). Acute pancreatitis showed no significant association with obesity or BSA. Importantly, development of AAT did not increase the likelihood of EOI MRD positivity (36.6% vs 33.5%; Ps= .318), suggesting that induction toxicities did not adversely affect early disease response.
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Source: Orgel, E., Maese, L. D., Devidas, M., et al. Toxicity From Asparaginase During Acute Lymphoblastic Leukemia Induction: A Report From the Children's Oncology Group. Blood Advances. 2026; 10(14):4923-4930. Published: July 28, 2026. DOI: 10.1182/bloodadvances.2026019870
Single-Encounter Augmented Reality-Guided Localization for Resection of Suspected Early-Stage Lung Cancer
Single-encounter augmented reality (AR)-guided localization demonstrated noninferiority to conventional CT-guided localization for successful sublobar resection in patients with suspected early-stage lung cancer. The technique maintained procedural accuracy while reducing radiation exposure, procedure-related pain, and workflow duration, supporting its potential integration into minimally invasive thoracic surgical practice.
KEY FINDINGS: This randomized clinical trial demonstrated that single-encounter AR-guided localization was noninferior to conventional CT-guided localization for achieving successful sublobar resection of suspected early-stage lung cancer. In addition to maintaining localization accuracy, the AR-guided approach reduced radiation exposure, procedural pain, and workflow time, supporting its potential as an alternative localization strategy for minimally invasive lung surgery.
BACKGROUND: Accurate preoperative localization is critical for successful sublobar resection of small pulmonary nodules suspicious for early-stage lung cancer. Conventional computed tomography (CT)-guided localization typically requires multiple encounters, including localization in the CT suite followed by transfer to the operating room, increasing patient discomfort, radiation exposure, and procedural complexity. This randomized clinical trial evaluated whether a single-encounter augmented reality (AR)-guided localization strategy could achieve surgical outcomes comparable to standard CT-guided localization while improving procedural efficiency and patient experience.
DETAILS: This multicenter, randomized, noninferiority trial was conducted at 5 centers in China between August 8, 2024, and September 30, 2025. Among 296 randomized patients, 270 were included in the modified intention-to-treat analysis, with 134 assigned to single-encounter AR-guided localization and 136 to conventional multiple-encounter CT-guided localization. Eligible participants had CT-detected pulmonary nodules suspicious for early-stage lung cancer requiring preoperative localization before sublobar resection. The primary endpoint was successful sublobar resection, defined as R0 resection with protocol-specified adequate surgical margins. Secondary outcomes included localization accuracy, radiation exposure, localization-related complications, patient-reported pain, and procedural efficiency. The median (IQR) patient age was 59 (50-67) years, and 172 participants (63.7%) were women. Successful sublobar resection was achieved in 132 of 134 AR-guided procedures (98.5%) and 135 of 136 CT-guided procedures (99.3%), yielding a risk difference of -0.8 percentage points (95% CI, -2.7 to 3.9) and meeting the prespecified criterion for noninferiority. Localization accuracy was similar between groups, with a median (IQR) localization error of 3.0 (0.0-5.0) in the AR group and 3.0 (2.0-6.0) in the CT group. Compared with CT guidance, AR-guided localization significantly reduced radiation exposure (456.50 [378.75-631.85] vs 1260.11 [1026.48-1544.53] mGy·cm; P<.001), preoperative pain (0 [0-0] vs 5 [4-6]; P<.001), puncture time (0.63 [0.50-0.83] vs 6.50 [5.00-8.75] minutes; P<.001), and localization-to-incision interval (2.00 [1.50-2.00] vs 33.50 [18.00-63.00] minutes; P<.001). Pneumothorax occurred in 40 of 136 CT-guided cases (29.4%), whereas no clinically significant complications associated with AR-guided localization were reported.
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Gadolinium-Based Contrast Agents: Reassessing Safety Beyond Nephrogenic Systemic Fibrosis
This review highlights that gadolinium-based contrast agents continue to play a critical role in diagnostic MRI, but their use should be guided by careful patient selection and individualized risk assessment. Although the risk of nephrogenic systemic fibrosis has declined considerably, further research is needed to clarify the clinical significance of gadolinium retention and its long-term safety.
KEY FINDINGS: This review emphasizes that GBCAs remain indispensable for diagnostic MRI but should be used following an individualized benefit-risk assessment, particularly in patients with chronic kidney disease or acute kidney injury. Although modern practice has substantially reduced the incidence of NSF, uncertainties remain regarding gadolinium retention, long-term toxicity, and persistent symptoms after exposure. Continued research into the mechanisms of gadolinium-associated injury, along with transparent patient counseling and evidence-based imaging policies, will be essential to optimize both patient safety and diagnostic care.
BACKGROUND: Gadolinium-based contrast agents (GBCAs) have been widely used to enhance magnetic resonance imaging (MRI) since the 1980s because of their favorable diagnostic performance and generally low incidence of acute adverse reactions. However, concerns regarding nephrogenic systemic fibrosis (NSF), gadolinium retention, and potential long-term toxicity have prompted ongoing debate about their safety, particularly in patients with kidney disease. This review examines current evidence on GBCA-associated complications, mechanisms of toxicity, and considerations for balancing diagnostic benefits with potential risks.
DETAILS: This narrative review synthesizes published evidence on the clinical safety of GBCAs, including acute hypersensitivity reactions, nephrotoxicity, NSF, gadolinium retention, and emerging concepts such as gadolinium-associated symptoms. The authors discuss differences between linear and macrocyclic GBCAs, proposed mechanisms of tissue deposition and fibrosis, the role of kidney dysfunction in gadolinium elimination, current American College of Radiology (ACR) recommendations, and unresolved questions regarding long-term toxicity. Experimental and clinical data addressing tissue retention, dialysis, and mechanistic pathways underlying gadolinium-induced injury are also reviewed. The review highlights that the incidence of NSF has declined substantially following the adoption of risk-based prescribing practices and updated clinical guidelines. Nevertheless, available evidence indicates that gadolinium retention can occur in multiple tissues, including the brain, even in individuals without severe renal impairment. The authors emphasize that tissue retention and toxicity are not fully explained by current GBCA classifications and that macrocyclic agents, although generally considered more stable, do not completely eliminate potential risk. Evidence reviewed also suggests that gadolinium may contribute to acute kidney injury, persistent tissue deposition, rare cases of encephalopathy, and symptoms associated with gadolinium exposure. Current data do not establish a definitive exposure threshold for toxicity, and the benefit of prophylactic hemodialysis after GBCA administration remains uncertain. While observational studies have estimated the risk of NSF with group II agents to be below 0.07%, the review notes that the true absolute risk remains difficult to define because of limitations in available evidence and confounding factors.
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