- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date, Metastases: PRIME-CUT: REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov) - Apr 4, 2022 P2, N=20, Recruiting, Lack of conclusive comparative evidence makes it imperative to have a holistic approach of considering the patient profile and the disease characteristics to select the appropriate GnRH-A for ADT in prostate cancer. Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Sep 2020 --> Dec 2022
- |||||||||| Herceptin (trastuzumab) / Roche
Journal: Poorly Differentiated Scrotal Carcinoma With Apocrine Immunophenotype. (Pubmed Central) - Mar 23, 2022 Molecular analysis (n = 2) detected a HER-2 mutation in one and microsatellite instability in another. Although the presence of an intraepidermal pagetoid component could hint toward the diagnosis of invasive extramammary Paget disease, tumors without an intraepidermal component could be diagnostically challenging given the lack of morphologic evidence of apocrine differentiation.
- |||||||||| Xeljanz (tofacitinib) / Pfizer, Humira (adalimumab) / Eisai, AbbVie
Recalcitrant Pediatric Bullous Erythema Multiforme Responsive to Oral Tofacitinib (Poster Presentation Center 1) - Mar 21, 2022 - Abstract #AAD2022AAD_2427; Adjunctive therapies including acyclovir and leuprolide had also proven ineffective.Physical examination revealed well-defined, targetoid macules with central vesiculation scattered upon all four extremities...Scattered, erythematous erosions were seen on the hard palate and buccal mucosa; in addition, the lips featured hemorrhagic crusts.Biopsies: Punch biopsies of lesions obtained from the left arm revealed a brisk lymphocytic infiltrate at the dermoepidermal junction with necrotic keratinocytes observed at all levels of the epidermis.Laboratory Data: Further work-up revealed negative PCR for EBV & CMV, negative ANA, negative HIV, negative Mycoplasma antibodies, and negative HSV-2 & HSV-2 antibodies.Diagnosis: Bullous erythema multiforme.Clinical Course and Treatment: Patient was transitioned to oral tofacitinib 5 mg twice daily with corresponding complete resolution of active lesions. Disease activity has remained quiescent for over two years, which represents the longest period of time without a disease flare since the patient’s initial diagnosis during childhood.
- |||||||||| leuprorelin depot / Generic mfg., tamoxifen / Generic mfg.
Clinical, Journal: Role of leuprorelin on ovarian function of patients with receptor-positive premenopausal breast cancer. (Pubmed Central) - Mar 16, 2022 The quality of life score and activity of life score in the observation group were higher. Leuprorelin combined with endocrine drugs can obviously protect ovarian function with significant long-term effect, which effectively reduces the impact of adverse reactions on receptor-positive PBC patients, with higher safety and better feasibility.
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Erleada (apalutamide) / J&J, Firmagon (degarelix) / Astellas, Ferring
Trial initiation date, Metastases: OMPCa-ENSURE: Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer (clinicaltrials.gov) - Mar 16, 2022 P2, N=160, Recruiting, Leuprorelin combined with endocrine drugs can obviously protect ovarian function with significant long-term effect, which effectively reduces the impact of adverse reactions on receptor-positive PBC patients, with higher safety and better feasibility. Initiation date: Jan 2022 --> Apr 2022
- |||||||||| leuprorelin depot / Generic mfg.
Clinical, Journal: Effects of Gonadotropin-Releasing Hormone Analogs on Ovarian Function Against Chemotherapy-Induced Gonadotoxic Effects in Premenopausal Women With Breast Cancer in China: A Randomized Clinical Trial. (Pubmed Central) - Mar 15, 2022 P3 This randomized clinical trial, conducted at the Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital and Zhejiang Cancer Hospital in China, was an open-label trial involving premenopausal women aged 18 to 49 years with operable stage I to III breast cancer for which treatment with adjuvant or neoadjuvant cyclophosphamide-containing chemotherapy was planned in 2 parallel groups: treatment with chemotherapy with or without GnRHa...In patients randomized to receive GnRHa, 3.6 mg of goserelin or 3.75 mg of leuprorelin was injected subcutaneously once every 28 days from 1 to 2 weeks before the first cycle of chemotherapy to 4 weeks after the last cycle of chemotherapy...This randomized clinical trial found that administering GnRHa in treatment with chemotherapy for premenopausal patients with breast cancer reduces the risk of POI, which promotes the recovery of ovarian function. ClinicalTrials.gov Identifier: NCT02518191.
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Late onset of pituitary apoplexy following gonadotropin-releasing hormone agonist for prostate cancer treatment. (Pubmed Central) - Mar 15, 2022 We present a case of a man in his late 50s who developed PA following treatment of PCa with leuprolide...Anterior pituitary hormone workup along with pituitary MRI confirmed the diagnosis of PA and patient was subsequently treated with adequate replacement of pituitary hormone with significant improvement in his symptoms. It is very important to keep a high index of suspicion for PA, especially among elderly patients receiving GnRH agonist treatment for PCa.
- |||||||||| Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Clinical, P3 data, Journal, Head-to-Head: Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study. (Pubmed Central) - Mar 9, 2022 P3 Relugolix was noninferior to LEU for treating endometriosis-associated pelvic pain. Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment.
- |||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Cost-Effectiveness Analysis of Androgen Deprivation Therapy with Relugolix for the Treatment of Advanced Prostate Cancer (Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_1659; Though the influence of adverse events was not considered in the analysis, ADT with relugolix was not a cost-effective choice for the treatment of APC when compared to ADT with leuprolide. While the analysis revealed that patients had a slight chance of sustaining testosterone suppression with relugolix in terms of PFS, ADT with relugolix provided no overall survival advantages over ADT with leuprolide.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., docetaxel / Generic mfg.
Trial completion: A Registry for Patients Treated on the Clinical Trial TAX 3503 (clinicaltrials.gov) - Mar 8, 2022 P3, N=52, Completed, While the analysis revealed that patients had a slight chance of sustaining testosterone suppression with relugolix in terms of PFS, ADT with relugolix provided no overall survival advantages over ADT with leuprolide. Active, not recruiting --> Completed
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Aggressive (deep) angiomyxoma of the vulva: a case report. (Pubmed Central) - Feb 25, 2022 Aggressive angiomyxoma is one of the differential diagnoses for vulvovaginal growth in a female. As the tumor is well known for local recurrences, correct diagnosis and appropriate management using a multidisciplinary approach are crucial to managing such patients.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Phase classification: The Effects of Reproductive Hormones on Mood and Behavior (clinicaltrials.gov) - Feb 24, 2022 P1/2, N=100, Completed, In conclusion, our study demonstrated that LA-CPSC injectable bone cement should be a viable solution to repair bone fractures under the osteoporotic conditions. Phase classification: P=N/A --> P1/2
- |||||||||| leuprorelin depot / Generic mfg.
Review, Journal: Potential effets of ginkgo (Ginkgo biloba, L.) on female reproduction. (Pubmed Central) - Feb 17, 2022 Impact of ginkgo action on reproductive organs other than ovaries remains largely unknown. Addressing these issues with proper animal and clinical studies could help to understand the distinct efficacy and consequences of medical application of ginkgo.
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Evolution of drug delivery systems: From 1950 to 2020 and beyond. (Pubmed Central) - Feb 17, 2022 In 2000, both Mylotarg™ (antibody-drug conjugate - gemtuzumab ozogamicin) and Rapamune® (sirolimus nanocrystal formulation) were introduced...As the development of COVID-19 vaccines demonstrated, meeting the unforeseen crisis of the uncertain future requires continuous cumulation of failures (as learning experiences), knowledge, and technologies. Conscious efforts of supporting diversified research topics in the drug delivery field are urgently needed more than ever.
- |||||||||| Firmagon (degarelix) / Astellas, Ferring
Enrollment closed, Monotherapy: High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov) - Feb 16, 2022 P1/2, N=163, Active, not recruiting, Conscious efforts of supporting diversified research topics in the drug delivery field are urgently needed more than ever. Suspended --> Active, not recruiting
- |||||||||| leuprorelin depot / Generic mfg., Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
GnRH antagonists: reduced CV risk vs leuprolide ▶️ Common AEs w/ oral relugolix: hot flash, fatigue, constipation, diarrhea, arthralgia, HTN #PCaChat (Twitter) - Feb 15, 2022
- |||||||||| leuprorelin depot / Generic mfg.
Journal: An Electrochemical Approach to Designer Peptide α-Amides Inspired by α-Amidating Monooxygenase Enzymes. (Pubmed Central) - Feb 10, 2022 The protocol leverages the inherent reactivity of C-terminal carboxylates, is compatible with the vast majority of proteinogenic functional groups, and proceeds in the absence of epimerization, thus addressing major limitations associated with conventional coupling-based approaches. The utility of the method is exemplified through the synthesis of natural product acidiphilamide A via a key diastereoselective reduction, as well as bioactive peptides and associated analogues, including an anti-HIV lead peptide and blockbuster cancer therapeutic leuprolide.
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