leuprolide acetate for depot suspension
/ Generic mfg.
- LARVOL DELTA
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June 25, 2025
LH-RH agonist monotherapy for androgen receptor-positive recurrent and/or metastatic salivary gland cancer: a retrospective study.
(PubMed, Int J Clin Oncol)
- "LH-RH agonist monotherapy demonstrated a well-balanced profile between efficacy and safety and could be an alternative therapeutic option, especially for subjects not tolerable to combination therapy. (242 words)."
Journal • Monotherapy • Retrospective data • Oncology • Salivary Gland Cancer • AR
June 21, 2025
Personalized neoadjuvant strategy using 70-gene assay to increase breast-conserving surgery in ER+/HER2- breast cancer.
(PubMed, NPJ Breast Cancer)
- "Patients classified as high genomic risk received NCT, while low-risk patients underwent NET (letrozole ± leuprolide for premenopausal women) for 16-24 weeks. Pathologic complete response occurred in 2.2%, exclusively in the NCT group. Thus, pretreatment genomic profiling effectively guided therapy selection, substantially increasing BCS eligibility while sparing low-risk patients unnecessary chemotherapy toxicity."
Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2
June 21, 2025
Pooled Analysis of the SOLAR and SATURN Clinical Trials Comparing Progression of Synchronous Versus Metachronous Prostate-specific Membrane Antigen-defined Oligometastatic Prostate Cancer Following Systemic and Tumor-directed Therapy.
(PubMed, Eur Urol Oncol)
- P2 | "All patients received 6 mo of intensified systemic therapy (leuprolide, abiraterone acetate with prednisone, and apalutamide) and stereotactic body radiotherapy to oligometastases. Among 50 patients (24 synchronous and 26 metachronous), the synchronous omCSPC group had a significantly higher PSA response rate (83% vs 50%; p = 0.018) and significantly longer PFS and eugonadal PFS (p < 0.05). The metachronous subgroup with prior ADT had worse outcomes, suggesting increasing resistance with repeated systemic therapy."
Journal • Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor
June 19, 2025
Interventions for fertility preservation in women with cancer undergoing chemotherapy.
(PubMed, Cochrane Database Syst Rev)
- "In women with breast cancer being treated with chemotherapy, the evidence is very uncertain about controlled ovarian hyperstimulation using gonadotropins plus a protective agent (letrozole or tamoxifen) compared to controlled ovarian hyperstimulation with gonadotropins in terms of the number of oocytes obtained. When comparing letrozole versus tamoxifen used as the protective agent, there is probably little to no difference in the number of oocytes retrieved. There is no evidence available for the long-term implications of controlled ovarian hyperstimulation protocols, such as their effects on live births or overall survival of women with breast cancer. In women with breast cancer, ovarian suppression using GnRH agonists may result in a large reduction in ovarian insufficiency caused by chemotherapy, but the certainty of the evidence is low. Evidence for other outcomes is of low or very low certainty. We are not able to reach any conclusions concerning the choice of..."
Clinical • Journal • Review • Breast Cancer • Fatigue • Gynecology • Hematological Disorders • Leukopenia • Oncology • Ovarian Cancer • Pain • Solid Tumor • Women's Health
June 18, 2025
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
(clinicaltrials.gov)
- P2 | N=40 | Not yet recruiting | Sponsor: Icahn School of Medicine at Mount Sinai
New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor
June 16, 2025
GnRH analogues and dienogest for second line treatment of endometriosis-associated pain: a systematic review, meta-analysis, and network meta-analysis.
(PubMed, Eur J Obstet Gynecol Reprod Biol)
- "Oral GnRH antagonist has shown to be the most effective in improving dysmenorrhea and NMPP, as compared to the other drugs. However, dienogest was found more beneficial in the treatment of dyspareunia. These finding may serve clinical practitioners in electing medical therapy."
Journal • Retrospective data • Review • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health
April 23, 2025
Intensification of androgen deprivation therapy (ADT) in metastatic hormone sensitive prostate cancer (mHSPC): Patterns of use and impact on outcomes from a large academic medical center.
(ASCO 2025)
- "Funded by No funding sources reported Background: ADT intensification with docetaxel and/or androgen receptor pathway inhibitors (ARPIs) has survival benefit in mHSPC...Leuprolide (85.3%), relugolix (12.1%) or degarelix (2.7%) were used for ADT. Of those who RI, 80.3% received an ARPI; 62.3% received abiraterone, 14.6% darolutamide, 13.9% apalutamide, and 9.3% enzalutamide... While PFS was longer for those who RI, these pts also had higher volume of disease, higher PSA, and higher rates of de novo disease, likely contributing to poorer OS. Even at a large academic institution, only about half of pts received intensification. Pts not given intensification were older, and patient preference was the most commonly identified reason for not receiving intensification."
Metastases • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor
June 12, 2025
…Reimbursement review…
(Korea Biomedical Review)
- "The Health Insurance Review and Assessment Service (HIRA) held its fifth CDRC meeting on Wednesday....AstraZeneca's Zoladex LA Depot (goserelin acetate), Takeda Korea’s Leuplin DPS (leuprorelin acetate), and Sanofi Aventis-Korea’s Eloxatin (oxaliplatin), which aimed at expanding coverage, also failed to cross the threshold....AstraZeneca's Zoladex for breast cancer in premenopausal and perimenopausal women who are candidates for hormonal therapy, Takeda's Leuprin DPS for premenopausal breast cancer, and Sanofi's Eloxatin in combination with docetaxel and S-1 (tegafur, gimeracil, oteracil potassium) for preoperative adjuvant therapy for resectable locally advanced gastric cancer failed to gain coverage."
Reimbursement • Breast Cancer • Gastric Cancer
June 11, 2025
The Effect of Leuprolide Acetate 11.25 mg 3-Month Formulation in Children with Central Precocious Puberty: A Systematic Review and Meta-analysis.
(PubMed, Adv Ther)
- "LA 11.25 mg 3-month formulation is efficacious in suppressing LH, FSH peak and other gonadal hormones and slowing the bone age and growth velocity in children with CPP."
Journal • Retrospective data • Review • Endocrine Disorders • Pain
June 11, 2025
A Clinical Study of KLH-2109 in Patients With Endometriosis
(clinicaltrials.gov)
- P3 | N=288 | Recruiting | Sponsor: Kissei Pharmaceutical Co., Ltd.
New P3 trial • Endometriosis • Gynecology • Women's Health
June 11, 2025
Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW
(clinicaltrials.gov)
- P1 | N=13 | Completed | Sponsor: Johns Hopkins University | Recruiting ➔ Completed | N=20 ➔ 13 | Trial completion date: Nov 2025 ➔ Mar 2025 | Trial primary completion date: Jul 2025 ➔ Mar 2025
Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease
June 05, 2025
GnRHa 45 mg SC LA Positively Impacts Predicted Adult Height Depending on the Degree of Bone Age Advancement
(ENDO 2025)
- "Unanswered questions remain about the benefits regarding height enhancement of starting GnRHa treatment at chronological age (CA) 12 years.Aims: To perform secondary analyses of impact on predicted adult height (PAH) depending on the degree of BA advancement using data from the pivotal trial of the first small-volume, long-acting, subcutaneously administered leuprolide acetate for CPP. 62 children (60 girls) with treatment-naïve CPP received 2 doses of 45 mg subcutaneous leuprolide acetate (SC LA) at 24-week intervals over the 48-week study period... 45 mg SC LA increases PAH by ~3-5 cm in girls over 48 weeks treatment across a range of BA/CA categories. Girls with BA/CA ≥1.4 showed benefit from treatment by week 24 which persisted until at least week 48. For girls with BA/CA ≤1.4, longer treatment may be needed to observe PAH increase."
Clinical • Endocrine Disorders
April 27, 2025
Progesterone Hypersensitivity Manifesting as Cyclical Urticaria
(ENDO 2025)
- "A leuprolide-induced progesterone suppression test, a diagnostic procedure involving leuprolide administration to suppress endogenous progesterone production, was performed instead. Progesterone hypersensitivity should be considered in the differential diagnosis of cyclical urticaria/allergic reactions, especially if they are noticed to occur in the luteal phase of the menstrual cycle."
Dermatology • Gynecology • Immunology • Urticaria • Women's Health
April 27, 2025
GnRH Agonist Therapy Induced Pituitary Apoplexy
(ENDO 2025)
- "Here, we report a case of a patient with no prior diagnosis of pituitary adenoma, who developed pituitary apoplexy in the context of GnRH agonist therapy for in vitro fertilization (IVF).Case Presentation: A 31-year-old female with a history of infertility and recurrent miscarriages presented with acute onset intractable headache, nausea and dizziness a few days after her initial round of IVF utilizing a micro-Lupron flare protocol for egg retrieval... Pituitary apoplexy, although rare, has been reported in association with GnRH agonist therapy, typically in patients with pre-existing gonadotropin-secreting or nonfunctioning pituitary adenomas. The latency between treatment and symptoms onset is variable. The proposed pathophysiologic mechanism involves pituitary stimulation by GnRH agonists, potentially leading to the underlying adenoma's growth and subsequent tissue infraction or hemorrhage."
CNS Disorders • Gynecology • Hematological Disorders • Infertility • Pain • Pituitary Gland Carcinoma • Sexual Disorders
June 05, 2025
Pituitary Apoplexy Following Gonadotropin-Releasing Hormone Agonist Therapy: A Rare and Life-Threatening Complication.
(PubMed, Cureus)
- "We present the case of a 59-year-old male with a history of type 2 diabetes mellitus, hypertension, hyperlipidemia, and prostate cancer who developed intractable headache, nausea, vomiting, photophobia, and blurred vision shortly after receiving a leuprolide, GnRH agonist injection, for the treatment of prostate cancer...Clinicians should maintain a high index of suspicion for pituitary apoplexy in patients presenting with acute neurological or endocrine symptoms following GnRH agonist therapy. Increased awareness and vigilance in at-risk populations are essential, as routine pre-screening for pituitary adenomas is not currently standard practice."
Journal • Brain Cancer • Cardiovascular • Diabetes • Dyslipidemia • Endocrine Cancer • Genito-urinary Cancer • Hematological Disorders • Hypertension • Metabolic Disorders • Oncology • Pain • Pituitary Gland Carcinoma • Prostate Cancer • Solid Tumor • Type 2 Diabetes Mellitus
April 27, 2025
Contrasting Clinical Presentations of Pediatric Leydig Cell Tumors: Two Cases with Unique Features
(ENDO 2025)
- "A Lupron stimulation test was performed with a non-pubertal peak LH of 4.9 IU/L (< 5 IU/L)...The first case demonstrates the classic presentation with peripheral precocious puberty, whereas the second case highlights progression to central precocious puberty, which complicated the diagnostic process. More studies are needed to determine baseline characteristics of Leydig tumors and risk factors for progression to central precocious puberty."
Clinical • Endocrine Disorders • Oncology • Pediatrics • Solid Tumor • Testicular Cancer
April 27, 2025
Effectiveness of 6-Month Gnrha Formulations for Pubertal Suppression in Youth Assigned Male-At-Birth
(ENDO 2025)
- "In addition to monthly and three-monthly formulations, new long-acting GnRHa products, triptorelin and leuprolide acetate (Triptodur® and Fensolvi®) have been approved for use in central precocious puberty (CPP). The majority of TG/NB patients AMAB in our study achieved pubertal suppression (biochemical, clinical, or both) with Triptodur® or Fensolvi® based on strict criteria used for CPP. Of those with subjective data, all reported adequate suppression. This study provides novel clinical and biochemical data of TG/NB patients AMAB on long-acting GnRHa formulations, Triptodur® and Fensolvi®, which can guide clinicians in their care."
Endocrine Disorders
April 27, 2025
Pubertal Suppression for Youth Assigned Female At Birth: Experience With 6-Month Formulations
(ENDO 2025)
- "Within the last decade, new long-acting GnRHa formulations, triptorelin and leuprolide acetate (Triptodur® and Fensolvi®) were approved for use in central precocious puberty (CPP). Extrapolating suppression criteria from the CPP literature, the majority of TG/NB patients AFAB achieved or maintained pubertal suppression (biochemical and/or clinical) with Triptodur® or Fensolvi®. To our knowledge, our study is the first one to provide clinical and biochemical data of TG/NB patients AFAB on long-acting GnRHa formulations, Triptodur® and Fensolvi®, which can serve as a guide to clinicians."
Endocrine Disorders
April 27, 2025
Metastatic Prostate Cancer Masquerading as Paget's Disease of Bone: A Case Report
(ENDO 2025)
- "Antiandrogen therapy (Bicalutamide) and gonadotropin-releasing hormone agonist (Leuprolide acetate) treatment for metastatic prostate cancer was initiated with biochemical improvement in PSA level. This case illustrates the diagnostic challenges in differentiating Polyostotic PDB from metastatic bone disease, in an elderly man with overlapping clinical and radiological findings. It is crucial for physicians, to consider metastatic prostate cancer in the differential diagnosis when encountering bone lesion that could be mistaken for Paget's disease of bone.Biopsy and histological examination are often necessary to distinguish between these conditions definitely. Multidisciplinary care and close coordination among specialties are vital to ensure accurate diagnosis and optimal patient management."
Case report • Clinical • Metastases • Alzheimer's Disease • Asthma • Cachexia • Cardiovascular • CNS Disorders • Dementia • Dyslipidemia • Genito-urinary Cancer • Hypertension • Immunology • Oncology • Pain • Prostate Cancer • Rare Diseases • Respiratory Diseases • Solid Tumor
April 23, 2025
Use of Epic SlicerDicer to assess pregnancy rates in adolescent and young adult patients with breast cancer.
(ASCO 2025)
- "We collected descriptive statistics on age, national percentile area deprivation index, top 10 grouped ICD diagnoses, post-diagnosis pregnancy rate, use of leuprolide or goserelin, oncologic therapies, and surgeries. Electronic medical record data can be used to obtain real-time practice and sexual health patterns in oncology populations. Pregnancies were observed across nearly all therapy groups, highlighting the importance of fertility counseling and family planning discussions for AYA breast cancer patients. This study demonstrates the utility of tools like Epic Slicer Dicer in assessing reproductive outcomes in this unique patient population."
Clinical • Breast Cancer • Gynecology • Oncology • Solid Tumor
April 23, 2025
Secondary outcomes by prior definitive treatment (tx) in patients (pts) with high-risk biochemically recurrent prostate cancer (hrBCR) treated with enzalutamide (enza) plus leuprolide (combo): EMBARK post hoc analysis.
(ASCO 2025)
- P3 | "Tx with combo vs leuprolide alone showed improvements in all secondary endpoints by prior definitive tx, which supports the benefits of combo as the new standard of care for pts with hrBCR regardless of prior definitive tx. The small sample sizes of the nonrandomized subgroups and low event numbers should be considered when interpreting results. There were no interactions by prior tx for two key secondary endpoints."
Clinical • Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor
April 23, 2025
Comparative outcomes of abiraterone and androgen receptor inhibitors (ARPIs) in metastatic castration-sensitive prostate cancer (mCSPC): A real-world analysis from the TriNetX database.
(ASCO 2025)
- " Using the TriNetX Research Network (2010–2024), we identified mCSPC patients treated with abiraterone (n=681), enzalutamide (n=252), or apalutamide (n=121) in combination with ADT (91–98% receiving a GnRH analog, primarily leuprolide). Outcomes included the risk of hormone resistance (ICD-10 Z19.2) and a combined endpoint of hormone resistance or docetaxel use... This real-world analysis highlights significant differences in treatment outcomes for mCSPC. Enzalutamide was associated with the highest risk of progression, while apalutamide demonstrated the most favorable outcomes, including higher sustained PSA reductions and lower progression risk. Baseline PSA differences may partially explain these findings."
Clinical • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor
April 23, 2025
Prognostic relevance of Aurora kinase A (AURKA) expression in prostate cancer (PCa).
(ASCO 2025)
- "Interestingly, Q4 was associated with a longer Leuprolide-TOT (HR: 0.9(0.8-0.97), p<0.01) and a shorter Enzalutamide-TOT (HR: 1.2 (1-1.4), p<0.05) Analysis of a large dataset revealed that high AURKA expression correlates with poor prognosis across clinical and demographic subpopulations. Analysis of a large dataset revealed that high AURKA expression correlates with poor prognosis across clinical and demographic subpopulations. AURKA inhibitors might enhance outcomes of metastatic PCa treated with AR pathway inhibitors by intensifying AR inhibition, increasing DNA-damage-related cell death, and/or preventing escape mechanisms like NEPC. Further studies are needed to identify contexts where AURKA inhibitors can improve metastatic PCa outcomes."
Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AURKA • PTEN • RB1 • TP53
April 23, 2025
Secondary outcomes by prior definitive treatment (tx) in patients (pts) with high-risk biochemically recurrent prostate cancer (hrBCR) treated with enzalutamide (enza) monotherapy (mono): EMBARK post hoc analysis.
(ASCO 2025)
- P3 | "Funded by The study was sponsored by Pfizer Inc. Tx with enza mono showed improvements in all secondary endpoints except time to resumption of any hormonal therapy vs leuprolide alone, regardless of prior definitive tx. The small sample sizes of the nonrandomized prior tx subgroups and low event numbers should be considered when interpreting the results. Interaction analyses of secondary endpoints across prior definitive tx subgroups will be reported in the presentation."
Clinical • Monotherapy • Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor
April 23, 2025
Adjuvant WIDER: A phase 3b trial of ribociclib (RIB) + endocrine therapy (ET) as adjuvant treatment (tx) in a close-to-clinical-practice patient (pt) population with HR+/HER2− early breast cancer (EBC).
(ASCO 2025)
- P3 | "Pts will receive RIB (400 mg/d; 3 wk on/1 wk off) + ET (letrozole 2.5 mg/d, anastrozole 1 mg/d, or exemestane 25 mg/d) for 36 months, followed by ET alone as SOC per investigator's clinical judgment. Pre/peri-menopausal women and men will receive goserelin 3.6 mg or leuprolide 3.75 mg/4 wk...Recruitment is ongoing. Clinical trial information: NCT05827081."
Clinical • P3 data • Breast Cancer • Heart Failure • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • HER-2
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