Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.

Cancer drug development remained robust in 2023. Highlights of U.S.

National survey findings on law enforcement agency drug response practices, overdose victim outcomes, and Good Samaritan Laws.

Background: The United States continues to experience unprecedented rates of overdose mortality. Addressing the overdose epidemic has been challenging for policy makers given the lack of effectiveness of existing drug control policy measures. More recently, the implementation of harm reduction-based policies such as Good Samaritan Laws has led to increasing scholarly attention aimed at evaluating their effectiveness at reducing the likelihood of criminal justice-related sanctions for individuals following an overdose incident.

The Impact of Improved Treatments on Survival of Adult U.S. Leukemia Patients: 1990-2018.

Introduction: Molecularly targeted therapies such as tyrosine kinase inhibitors (TKI) are effective treatments for B-cell receptor (BCR)-ABL-bearing leukemias. We evaluated the impact of TKIs on historical chronic myeloid leukemia (CML) mortality trends compared with acute lymphoblastic leukemia (ALL) and chronic lymphoblastic leukemia (CLL).

Methods: Because mortality trends reflect combined effects of leukemia incidence and survival, we also evaluated the contribution of incidence and survival trends to mortality trends by subtypes.

Post-overdose follow-up in the community with peer recovery specialists: The Lake Superior Diversion and Substance Use Response Team.

Background: As the overdose epidemic continues to worsen, nonfatal overdose calls for service represent a critical touchpoint for intervention. While most studies have focused on law enforcement led post-overdose follow-up, the current study describes the programmatic characteristics and outcomes of a non-law enforcement post overdose program comprised of peer specialists embedded within a local police department.

Methods: We examined information on 341 follow-up responses occurring over a 16-month study period using administrative data.

Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective.

Minimal residual disease (MRD) is increasingly used as a prognostic biomarker, a measure of clinical efficacy, and a guide for treatment decisions in various hematologic malignancies. We sought to characterize MRD data in registrational trials in hematologic malignancies submitted to the U.S.

A national survey of law enforcement post-overdose response efforts.

Law enforcement agencies in the US have provided naloxone to officers and developed initiatives to follow-up after a non-fatal overdose. However, the prevalence and characteristics of these efforts have yet to be documented in research literature. We sought to understand the national prevalence of naloxone provision among law enforcement and examine the implementation of post-overdose follow-up.

Neuronal cilia in energy homeostasis.

A subset of genetic disorders termed ciliopathies are associated with obesity. The mechanisms behind cilia dysfunction and altered energy homeostasis in these syndromes are complex and likely involve deficits in both development and adult homeostasis. Interestingly, several cilia-associated gene mutations also lead to morbid obesity.

FDA approval summary: Crizotinib for pediatric and young adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.

In January 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

Perspectives from law enforcement officers who respond to overdose calls for service and administer naloxone.

Background: Many law enforcement agencies across the United States equip their officers with the life-saving drug naloxone to reverse the effects of an opioid overdose. Although officers can be effectively trained to administer naloxone, and hundreds of law enforcement agencies carry naloxone to reverse overdoses, little is known about what happens on scene during an overdose call for service from an officer's perspective, including what officers perceive their duties and responsibilities to be as the incident evolves.

Methods: The qualitative study examined officers' experiences with overdose response, their perceived roles, and what happens on scene before, during, and after an overdose incident.

The Association of Traumatic Brain Injury, post-traumatic stress disorder, and criminal recidivism.

Background: The purpose of the study was to assess the prevalence of traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) and to determine whether TBI or PTSD is associated with an increase in general or violent criminal recidivism among a representative sample of released prisoners. In-person interviews were conducted with a stratified random sample of individuals incarcerated with the South Carolina Department of Corrections approximately 90 days prior to the prisoners' releases. In addition to a variety of items and scales, respondents were screened for TBI and were asked whether they had received a current diagnosis of PTSD.

Association between law enforcement seizures of illicit drugs and drug overdose deaths involving cocaine and methamphetamine, Ohio, 2014-2019.

Background: The United States continues to experience a crisis of mounting opioid overdose deaths involving cocaine and methamphetamine (hereafter illicit stimulants). Law enforcement drug seizure data present a unique opportunity to examine the association between illicit-stimulant-involved overdose deaths (ISODs) and the illicit drug supply. Our objective is to better understand correlations between illicit drug market trends and increases in ISODs in Ohio in 2014-2019.

Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies: ACCELERATE in collaboration with the European Medicines Agency with the participation of the Food and Drug Administration.

The first (2017) and sixth (2021) multistakeholder Paediatric Strategy Forums focused on anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies. ALK is an important oncogene and target in several paediatric tumours (anaplastic large cell lymphoma [ALCL], inflammatory myofibroblastic tumour [IMT], neuroblastoma and hemispheric gliomas in infants and young children) with unmet therapeutic needs. ALK tyrosine kinase inhibitors have been demonstrated to be active both in ALK fusion-kinase positive ALCL and IMT.

The Hallux Metatarsophalangeal Capsule: An Anatomic Study With Respect to Percutaneous Hallux Valgus Correction.

Background: Minimally invasive surgery for the treatment of hallux valgus deformities has become increasingly popular. Knowledge of the location of the hallux metatarsophalangeal (MTP) proximal capsular origin on the metatarsal neck is essential for surgeons in planning and executing extracapsular corrective osteotomies. A cadaveric study was undertaken to further study this anatomic relationship.

FDA Approval Summary: Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

In June 2020, the U.S. Food and Drug Administration granted accelerated approval to selinexor for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

Comparison study of patient demographics and risk factors for surgical site infections following open reduction and internal fixation for lateral malleolar ankle fractures within the medicare population.

Background: The purpose of this study was to analyze a comprehensive database to 1) compare patient demographic profiles; and 2) identify patient-related risk factors for surgical site infections (SSIs) following open reduction and internal fixation (ORIF) for lateral malleolar ankle fractures.

Methods: Patients treated with ORIF for lateral malleolar ankle fractures that developed SSIs within 1-year following the procedure were identified. Study group demographics were compared to a control cohort and risks for developing SSI were calculated using multivariate logistic regression analysis.

FDA approval summary: Dalteparin for the treatment of symptomatic venous thromboembolism in pediatric patients.

On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium for the treatment of symptomatic venous thromboembolism (VTE) to reduce the risk of recurrence in pediatric patients 1 month of age and older.

FDA Approval Summary: Brentuximab Vedotin in First-Line Treatment of Peripheral T-Cell Lymphoma.

In November 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (BV) for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP).

Intracompartmental Versus Extracompartmental Transposition of the Extensor Pollicis Longus for Treating Thumb-in-Palm Deformity: A Biomechanical Comparison.

Purpose: Transecting the extensor pollicis longus (EPL) tendon and rerouting it through the first extensor compartment is an established technique for treating thumb-in-palm deformity (TIPD). An alternative technique that approximates the trajectory of the first extensor compartment without violating the compartment or transecting the EPL tendon can be accomplished by creating an artificial sheath from the extensor retinaculum to radialize the tendon glide path. This study compares this extracompartmental (EC) EPL transposition to the established, intracompartmental (IC) transposition by evaluating, in a cadaver model, the extent of thumb extension in both techniques.

Readability of the Most Commonly Accessed Arthroscopy-Related Online Patient Education Materials.

Purpose: To assess the readability and comprehension of written text by the most commonly visited websites containing patient education materials on common conditions that can be treated arthroscopically.

Methods: We examined 50 websites, assessed independently by 2 orthopaedic surgery residents (S.A.

Computer Assisted Cobb Angle Measurements: A novel algorithm.

Background: The standard for evaluating scoliosis is PA radiographs using Cobb angle to measure curve magnitude. Newer PACS systems allow easier Cobb angle calculations, but have not improved inter/intra observer precision of measurement. Cobb angle and its progression are important to determine treatment; therefore, angle variability is not optimal.