leuprolide acetate injection / Generic mfg. - LARVOL DELTA

Sterile abscess following intramuscular leuprolide acetate injection for endometriosis: A case report. (PubMed, J Pediatr Adolesc Gynecol) - "LA is a common treatment for refractory endometriosis in pediatric patients, but providers may be unaware of the risk of sterile abscess. We did not identify any predictive or preventative factors but propose that prior treatment may have increased risk in this case."

Journal • Endocrine Disorders • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Pediatrics • Women's Health

Zydus Life Science has obtained final USFDA approval for Leuprolide Acetate Injection, used in the palliative treatment of advanced prostatic cancer. (Scanx)

ANDA • Prostate Cancer

OCOG-RATIONAL: A phase II randomized trial of optimal recurrence-directed therapy (RDT) without or with androgen-deprivation therapy (ADT) in radio-recurrent oligo-metastatic castrate sensitive prostate cancer (romCSPC). (ASCO-GU 2025) - P2 | "Concurrent and adjuvant ADT involves four 3-month leuprolide acetate injections. This trial will provide evidence on the impact of ADT in romCSPC managed with optimal recurrence directed therapy. Findings will support phase III trial design to help define the optimal management of romCSPC in the future."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Transient synovitis associated with leuprolide depot (Lupron). (PubMed, Endocrinol Diabetes Metab Case Rep) - "A decision was made to initiate pubertal blockade using gonadotropin-releasing hormone agonist (GnRHa) therapy with depot leuprolide acetate injections every 3 months...The pain and discomfort continued to progress over the next 24 h despite an alternating regimen of Tylenol and ibuprofen prompting admission to the emergency department...Despite the long-acting formulation of depot leuprolide acetate, the systemic reaction in this case appears to be self-limited. Discontinuation of therapy or a change to an alternative formulation of GnRHa analog should be considered based on the need for therapy versus the potential risk of rechallenge."

Journal • Allergy • Endocrine Disorders • Immunology • Pain • CRP

Efficacy and Safety of Radiotherapy Plus Relugolix in Men With Localized or Advanced Prostate Cancer. (PubMed, JAMA Oncol) - "This multicenter post hoc analysis of patients with localized and advanced prostate cancer receiving radiotherapy in 2 randomized clinical trials (a phase 2 trial of relugolix vs degarelix, and a subset of the phase 3 HERO trial of relugolix vs leuprolide acetate) included men who were receiving radiotherapy and short-term (24 weeks) ADT (n = 103) from 2014 to 2015 and men receiving radiotherapy and longer-term (48 weeks) ADT (n = 157) from 2017 to 2019...Patients receiving longer-term ADT received relugolix, 120 mg, orally once daily (360-mg loading dose) or leuprolide acetate injections every 12 weeks for 48 weeks, with up to 90 days of follow-up...The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate cancer receiving radiotherapy. No new safety concerns were identified when relugolix was used with radiotherapy."

Clinical • Journal • Metastases • Atrial Fibrillation • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Pain • Prostate Cancer • Solid Tumor

EMBARK: subset analysis enzalutamide versus leuprolide in prostate cancer (YouTube) - P3 | N=1068| EMBARK (NCT02319837) | Sponsor: Pfizer | "Neal Shore, MD...discusses results from the Phase III EMBARK trial (NCT02319837) of enzalutamide monotherapy, or enzalutamide with leuprolide against placebo and leuprolide in patients with high-risk biochemically recurrent prostate cancer. Treatment suspension occurred in the enzalutamide monotherapy arm based on serum PSA response, leading to similar metastasis-free survival (MFS) rates with the leuprolide arm in the suspension group."

Interview • P3 data • Video

Testosterone Recovery for Relugolix Versus Leuprolide in Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. (PubMed, Eur Urol Oncol) - "Oral relugolix had faster and more complete recovery of testosterone to normal levels after treatment discontinuation than leuprolide acetate in a subset of men from the HERO study. The clinical implications of a faster testosterone recovery with relugolix may be significant for men being treated with androgen deprivation therapy and influence treatment decisions."

Journal • Metastases • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Neoadjuvant Cabazitaxel plus Abiraterone/Leuprolide Acetate in Patients with High-Risk Prostate Cancer: ACDC-RP Phase II Trial (Clin Cancer Res) - P2 | N=76 | ACDC-RP (NCT02543255) | "The per-protocol population consisted of 70 patients [cabazitaxel arm (Arm A): 37, no cabazitaxel arm (Arm B): 33]. Median patient age and prostate-specific antigen levels were 63.5 years [interquartile range (IQR), 58.0–68.0] and 21.9 ng/mL (IQR, 14.6–42.8), respectively. pCR/MRD occurred in 16 (43.2%) versus 15 patients (45.5%) in arms A and B, respectively (P = 0.85). pCR occurred in two (5.4%) versus three patients (9.1%) in arms A and B, respectively (P = 0.66). Patients with ≤ 25% total biopsy cores positive had increased odds of pCR/MRD (P = 0.04). Patients with pCR/MRD had superior 12-month BRFS rates (96.0% vs. 62.0%, P = 0.03)."

P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Diplopia and Headache After Treatment with GnRH agonist (ENDO 2023) - "Case Report: The Patient is a 46-year-old male with past medical history of hypertension and prostate cancer, currently undergoing treatment with leuprolide acetate injections, who presented to the emergency department with a complaint of worsening headache...The patient was started on desmopressin 0.1 mg po at bedtime and on intravenous dexamethasone 4 mg q6hrs...The patient reported an improvement in his left eye vision and lateral rectus palsyHe was transitioned to oral hydrocortisone 20 mg daily and 10 mg every afternoon prior to discharge... Patients with an undiagnosed pituitary adenoma are at risk of tumor expansion and mass effect as well as pituitary apoplexy during treatment with GnRH agonists. In our case clinical presentation was consistent with pituitary apoplexy without evidence of pituitary hemorrhage soon after GnRH agonist. A full ophthalmologic exam may be an appropriate screening prior to initiation of such therapy.*Unless otherwise noted, all..."

Cardiovascular • Endocrine Disorders • Genito-urinary Cancer • Hematological Disorders • Hypertension • Nephrology • Oncology • Ophthalmology • Otorhinolaryngology • Pain • Pituitary Gland Carcinoma • Prostate Cancer • Renal Disease • Solid Tumor • IGF1

Characterizing the Neural Substrates of Irritability in Women: A 7T fMRI Study (SOBP 2023) - "Methods HS+ participants (n=11) and HS- controls (n=12) received a baseline leuprolide acetate injection (Lupron; 3.75mg) to induce stable hypogonadism. Results After hormone add-back, HS+ (vs. HS-) participants showed increased activation in the pregenual anterior cingulate cortex (k=374) and left putamen (k=143) during rigged feedback relative to positive feedback (TFCE, p<0.05, uncorrected). Conclusions Preliminary analyses suggest HS+ participants show increased activation in regions specific to mood regulation and reward processing during frustration after inducing hormone changes similar to the perinatal period."

Clinical • CNS Disorders • Depression • Psychiatry

Cannabidiol as a potential novel treatment for endometriosis by its anti-inflammatory, antioxidative and antiangiogenic effects in an experimental rat model. (PubMed, Reprod Biomed Online) - "Due to its anti-inflammatory, antioxidative and antiangiogenic effects, CBD might be a therapeutic agent candidate for endometriosis."

Journal • Preclinical • Endometriosis • Gynecology • Inflammation • Oncology • Women's Health • IL6 • TNFA

Cipla launches prostate cancer-treating injection in USA (New Indian Express) - "NEW DELHI: Drug firm Cipla on Tuesday said it has launched Leuprolide Acetate Injection Depot 22.5 mg, used in the treatment of prostate cancer. The product was earlier approved by the US Food and Drug Administration based on a New Drug Application (NDA) regulatory pathway....The active ingredient, route of administration, dosage form and strength of the medication are the same as Abbvie's Lupron Depot. According to IQVIA, Lupron Depot (22.5 mg) had US sales of around USD 197 million for the 12-month period ending September 2022."

Generic launch • Genito-urinary Cancer • Oncology • Prostate Cancer

Amneal Pharma gets FDA nod for leuprolide acetate injection to treat prostate cancer (SeekingAlpha) - "Amneal Pharmaceuticals...said it had received an abbreviated new drug application approval from the U.S. FDA for its leuprolide acetate injection to treat prostate cancer. AMRX expects to launch eight new injectables in 2022, the company said in a statement."

ANDA • Launch • Genito-urinary Cancer • Oncology • Prostate Cancer