Presented at: ASCO virtual Meeting; 2020 May 29 – June 30. [5] Dustin D, et al. This updated second edition includes new information about medication and discusses various types of loss including that of a parent, child, spouse, friend, or pet. In this book, the development of next-generation batteries is introduced. Included are reports of investigations to realize high energy density batteries: Li-air, Li-sulfur, and all solid-state and metal anode (Mg, Al, Zn) batteries. This goal of this volume is to stimulate the reader to explore diverse ways to understanding the mechanism in which miRNAs facilitate the molecular aspects of the biomedical research. Particularly, Giredestrant has low metabolism and improved oral bioavailability, which led to the overall improvement of oral exposure in many species. Extensive research into the molecular mechanisms of cancer disease has heralded a new age of targeted therapy. [6] Clinicaltrials.gov. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. [15] Clinicaltrials.gov. All in all, Giredestrant is an orally active and selective estrogen receptor (ER) antagonist with anti-tumor activity. Importantly, Giredestrant has highly potent in vivo efficacy. Available from: https://clinicaltrials.gov/ct2/show/NCT04546009. Breast cancer is now the most common cancer in the world, with HR-positive being the most common subtype representing 70% of cases.1,2 Data from these studies will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 4-8, 2021.“We’re encouraged by the results of these ongoing giredestrant studies which form part of a comprehensive clinical development programme in HR-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. This book describes the state of the art in the application of NMR spectroscopy to metabolomics and will be a key title for researchers and practitioners. Subsequently, third generation aromatase inhibitors (AI) were proven superior to tamoxifen in post-menopausal women with advanced disease and approved in the early 2000s, at which point their evaluation . By using our website you agree to our use of cookies in accordance with our cookie policy. [16] Clinicaltrials.gov. Particularly, Giredestrant has low metabolism and improved oral bioavailability, which led to the overall improvement of oral exposure in many species. “Prolonged treatment durations and risk of relapse can represent significant challenges for patients, therefore a need remains for more effective and tolerable treatment options.”The data from two phase I studies presented at ASCO show giredestrant’s promising clinical activity and safety profile in HR-positive, HER2-negative breast cancer:NCT03916744: Interim analysis of this window of opportunity study in the post-menopausal, neoadjuvant (preoperative) setting showed giredestrant’s consistent and compelling activity.3, NCT03332797: Updated data from this phase I study in the locally advanced/metastatic breast cancer setting showed that giredestrant as a monotherapy was well-tolerated, and had promising clinical activity, irrespective of the type of prior therapy or the presence of ESR1 mutations (mutations in the ESR1 gene are important mechanisms of resistance to hormone therapy).4,5. 3-((1r,3r)-1-(2,6-difluoro-4-((1-(3-fluoropropyl)azetidin-3-yl)amino)phenyl)-3-methyl-1,3,4,9-tetrahydro-2h-pyrido[3,4-b]indol-2-yl)-2,2-difluoropropan-1-ol, 19. The uptake of tamoxifen into routine clinical practice has been made possible by its availability, low cost, and tolerable side-effect profile. [Internet; cited 2021 June]. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. Giredestrant (GDC-9545) is an orally active and selective estrogen receptor (ER) antagonist. Specifically, ERs are typical members of the nuclear receptor superfamily, including receptors that mediate steroid hormones, thyroid hormones, vitamin A and vitamin D, and many orphan receptors. Presented at ASCO Annual Meeting 2021, June 4-8. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. "A comprehensive overview of clinical laboratory toxicology services and analytes"-- The study is exploring the safety, pharmacokinetics, pharmacodynamics, and activity of giredestrant as a single agent, and in combination with palbociclib and/or luteinizing hormone-releasing hormone agonist, in 181 people with locally advanced or metastatic ER-positive/HER2-negative breast cancer. A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer. Roche is working with partners across the healthcare sector to provide the best care for each person.Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. An Amazon Best of the Month Book "For all the insight he offers into the hard science and thorny logistics of studying cancer, Dr. Scadden’s most moving passages consider the effect of the disease on the people who suffer from it and ... [13] Jhaveri K, et al. The basic side chain in giredestrant enables a full antagonist and consistent degradation profile which has been challenging to achieve for ER ligands including GDC-0810, AZD9496, LSZ102, and rintodestrant which have an acrylic acid moiety. And this is due to the particular combination of high binding potency, full suppression of ER signaling, and an improved DMPK profile. Giredestrant has a comprehensive development programme across a broad range of settings and treatment combinations for patients with HR-positive, HER2-negative breast cancer. The purpose of this review is to give an overview of the history of endocrine treatment, to clarify its role in the present standard of care, and to discuss the . The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track. The aims of this trial are to compare giredestrant and palbociclib with letrozole and palbociclib to find out: which works best for ER positive breast cancer that has spread. Giredestrant is a new drug. This book discusses the developments in the synthesis and functionalization of different heterocycles based on the formation of carbon-carbon (C-C) and carbon-heteroatom (C-X) bonds using cross-dehydrogenative coupling (CDC). C Metcalfe, et al. [4] Jhaveri KL et al. [8] Clinicaltrials.gov. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track, https://clinicaltrials.gov/ct2/show/NCT03916744, https://clinicaltrials.gov/ct2/show/NCT03332797. Dysfunction of ER pathway can lead to many diseases, such as hormone-dependent breast cancer, endometrial cancer and ovarian cancer, and so on. In the second place, Giredestrant is a clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. Nonetheless, Giredestrant has anti-tumor activity. [2] Tomas R and Barrios C. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Estrogen receptor (ERs) is a group of proteins found in cells and is activated by estrogen. Giredestrant was well-tolerated at all doses (10–250mg); there were no dose limiting toxicities with giredestrant monotherapy; AEs were generally low grade. Abstract #PD7-05. Meanwhile, Giredestrant potently competes with estradiol for binding and induces a conformational change within the ER ligand-binding domain. Written by specialists in breast cancer, the focus is on the whole patient, their family, and social networks, to make this book a holistic guide to better health at and after diagnosis with the disease, equipping patients affected by ... Genentech, in the United States, is a wholly owned member of the Roche Group. Please be aware that we do not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin. Abstract #P5-04-07. Ther Adv Med Oncol 2015;7(6):304-20. Meetings & Education ; Research & Data ; Practice & Patients ; Career Development ; News & Initiatives ; Get Involved Secondary endpoints include safety outcomes and plasma concentration of giredestrant.About NCT0333279716An ongoing phase Ia/b first-in-human, multi-centre, open-label, dose escalation, dose expansion study. Reliable, unbiased and up to date information in cancer research. [11] U.S Food and Drug Administration. 5. [Internet; cited 2021 June ]. [14] Lim E, et al. A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer). At 30mg, a 20% overall response rate was seen in patients with measurable disease at baseline, and clinical benefit rates of 55% and 76% were observed in the overall and ESR1 mutant subgroups, respectively. The primary endpoint of the study will be the change in Ki67 scores (a measure of how quickly cancer cells are proliferating) between biopsies taken before and after treatment. Abstract #1023. A standardised once-daily 30mg dose has been selected for the giredestrant development programme, both as a monotherapy and in combination studies. Safety and activity of single-agent giredestrant (GDC-9545) from a phase Ia/b study in patients (pts) with estrogen receptor-positive (ER+), HER2-negative locally advanced/metastatic breast cancer (LA/mBC). We are currently enrolling patients into two phase II studies (CoopERA and AcelERA) evaluating giredestrant in neoadjuvant oestrogen receptor (ER)-positive early breast cancer, and previously treated locally advanced or metastatic breast cancer respectively, as well as one phase III study (PersevERA), evaluating giredestrant plus palbociclib against letrozole plus palbociclib in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer.6,7,8The mainstay of treatment is to block oestrogen, but the side effects of this have a very significant impact on quality of life and can greatly affect treatment adherence.9,10 With giredestrant, we are striving to provide a more tailored, more effective and less debilitating treatment for HR-positive breast cancer.Giredestrant received U.S. Food and Drug Administration (FDA) Fast Track Designation (FTD) for ER-positive, HER2-negative, second and third-line metastatic breast cancer on 15 December 2020. [Internet; cited 2021 June]. 3-[(1r,3r)-1-[2,6-difluoro-4-[[1-(3-fluoropropyl)azetidin-3-yl]amino]phenyl]-3-methyl-1,3,4,9-tetrahydropyrido[3,4-b]indol-2-yl]-2,2-difluoro-propan-1-ol, 3-[(1R,3R)-1-[2,6-difluoro-4-[[1-(3-fluoropropyl)azetidin-3-yl]amino]phenyl]-3-methyl-1,3,4,9-tetrahydropyrido[3,4-b]indol-2-yl]-2,2-difluoropropan-1-ol, InChI=1S/C27H31F5N4O/c1-16-9-20-19-5-2-3-6-23(19)34-25(20)26(36(16)14-27(31,32)15-37)24-21(29)10-17(11-22(24)30)33-18-12-35(13-18)8-4-7-28/h2-3,5-6,10-11,16,18,26,33-34,37H,4,7-9,12-15H2,1H3/t16-,26-/m1/s1, CC1CC2=C(C(N1CC(CO)(F)F)C3=C(C=C(C=C3F)NC4CN(C4)CCCF)F)NC5=CC=CC=C25, C[C@@H]1CC2=C([C@H](N1CC(CO)(F)F)C3=C(C=C(C=C3F)NC4CN(C4)CCCF)F)NC5=CC=CC=C25, Gdc-9545, Unii-28p3du6db3, 28p3du6db3, 1953133-47-5, 3-[(1r,3r)-1-(2,6-difluoro-4-{[1-(3-fluoropropyl)azetidin-3-yl]amino}phenyl)-3-methyl-1,3,4,9-tetrahydro-2h-pyrido[3,4-b]indol-2-yl]-2,2-difluoropropan-1-ol, 3-((1r,3r)-1-(2,6-difluoro-4-((1-(3-fluoropropyl)azetidin-3-yl)amino)phenyl)-3-methyl-1,3,4,9-tetrahydro-2h-pyrido(3,4-b)indol-2-yl)-2,2-difluoropropan-1-ol, Chromatography (TLC / LC / HPLC / UPLC / GC), Complete Pharmacopoeial / Compendial Testing, Bioanalytical & Biomarker Testing Services, Bioequivalence / Clinical / Pre-Clinical Testing, Calculation and Modeling of Pharmacokinetic Parameters, Protein Isolation, Identification and Characterization, Electrical Conductivity / High Voltage Leak Detection (HVLD), Mass Flow / Mass Extraction Leak Detection, ASTM and ISTA Distribution Simulation Testing, Environmental Conditioning, Cycling and Simulation Testing, Controlled / Immediate / Modified Release, Health / Dietary Supplement (Nutraceutical), Low Temperature / Cryogenic Condition (-78 °C), Pharmacokinetics / Pharmacodynamics / Pharmacometrics, Clinical Research Translation / Validation, Pharmacovigilance / Product Lifecycle Management, High Potent / Biologic / Controlled Substance, Customization (Anodizing, Siliconization, Plastic Coating), Media / Public Relations / Communications, Methacrylic Acid - Ethyl Acrylate Copolymer, Methacrylic Acid Methyl Methacrylate Copolymer, Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer, Betadex Sulfobutyl Ether Sodium Excipient, Sodium Phosphate Dibasic 7-hydrate Excipient, Sodium Phosphate Dibasic Anhydrous Excipient, Sodium Phosphate Monobasic Anhydrous Excipient, Sodium Phosphate Monobasic Dihydrate Excipient, Sodium Phosphate Monobasic Monohydrate Excipient, Hydroxypropyl methylcellulose acetate succinate, Cross Linked Sodium Carboxymethylcellulose, Hepatology (Liver, Pancreatic, Gall Bladder). Abstract P5-04-07: GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. Cancer 2019;125(21):3714-28. Presented at ASCO Annual Meeting 2021, June 4-8. Secondary endpoints include plasma concentration levels of giredestrant and palbociclib over time, objective response rate, clinical benefit rate and duration of response.About RocheRoche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. This Test Guideline for developmental toxicity testing is designed to provide general information concerning the effects of prenatal exposure on the pregnant test animal and on the developing organism. What are the current industrial research problems and how can they be resolved in an industrial setting? This book highlights key methods that have real impact in drug discovery and facilitate delivery of drug molecules. All in all, Giredestrant is an orally active and selective estrogen receptor (ER) antagonist with anti-tumor activity. But, how does Giredestrant protect against cancer cells via ER? A phase Ib study to evaluate the oral selective estrogen receptor degrader GDC-9545 alone or combined with palbociclib in metastatic ER-positive HER2- negative breast cancer. A FTD is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.11About giredestrantGiredestrant is a next generation investigational SERD, designed to fully block ER signalling with robust receptor occupancy. GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. World J Clin Oncol 2014;5(3):248-62. This book presents state-of-the-art diagnoses and treatments available for bladder cancer that has metastasised into the body. [3]Moore HM et al. We use cookies to give you the best online experience. The series Topics in Heterocyclic Chemistry presents critical reviews on present and future trends in the research of heterocyclic compounds. Psycho-Oncology 2019;28:255-63. In this work, a dozen internationally renowned experts and leaders in the field bring the reader up to date by documenting and critically analyzing current developments and uses of metal-catalyzed cross-coupling reactions. This volume includes succinct overviews of breast cancer epidemiology, screening, staging, and treatment; overviews of all imaging modalities including mammography, tomosynthesis, ultrasound, and MRI; step-by-step approaches for image ... (1r,3r)-1-(2,6-difluoro-4-((1-(3-fluoropropyl)-3-azetidinyl)amino)phenyl)-beta,beta-difluoro-1,3,4,9-tetrahydro-3-methyl-2h-pyrido(3,4-b)indole-2-propanol, 20. Chapters detail major symptoms and conditions using a case study to introduce the topic and focusing on human responses to the condition. [Internet; cited 2021 June]. Giredestrant, a highly potent, nonsteroidal oral selective ER degrader, achieves robust ER occupancy, is active despite ESR1 mutations, and was well tolerated ± palbociclib with encouraging antitumor activity in the nonrandomized, open-label, dose-escalation and -expansion, phase Ia/b GO39932 study (NCT03332797; Jhaveri 2019; Lim 2020). Fast Track. Presented at: San Antonio Breast Cancer Symposium; 2018 December 4-8; San Antonio, Texas, USA. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. A standardised once-daily 30mg dose has been selected for the giredestrant development programme, both as a monotherapy and in combination studies.About NCT0391674415An open-label, short-term window study due to explore the safety, pharmacokinetics, pharmacodynamics, and activity of giredestrant in around 75 post-menopausal women with untreated stage I-III ER-positive/HER2-negative early breast cancer. A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer. "Cross-Coupling Reactions: An Overview opens with an overview of the fundamentals and applications of the young and fast developing area of transition metal catalyzed/mediated oxidative (dehydrogenative) C-H/C-H coupling reactions between ... Presented at: San Antonio Breast Cancer Symposium; 2019 December 10-14; San Antonio, Texas, USA. [10] Finitsis D, et al. Like other steroid receptors, ER mainly acts as ligand inducible transcription factors, which bind chromatin on specific reaction elements. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer). In the beginning, Giredestrant is a non-steroidal ER ligand and an orally active and selective ER antagonist. For more information, please visit www.roche.com.All trademarks used or mentioned in this release are protected by law.References[1] Sung H, et al. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. A first-in-human phase I study to evaluate the oral selective estrogen receptor degrader (SERD), GDC-9545, in postmenopausal women with estrogen receptor-positive (ER+) HER2-negative(HER2-) metastatic breast cancer. 9,10 With giredestrant, we are striving to provide a more tailored, more effective and less debilitating treatment for HR-positive breast cancer. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Besides, once ER is activated, estrogen can be transferred to the nucleus and bound to DNA, thus regulating the activity of different genes. The safety profile of giredestrant in the neoadjuvant setting was consistent with its mechanism of action and there were no discontinuations due to adverse events (AEs). Oestrogen encourages HR-positive breast cancer cells to grow by attaching to the ER. Abstract #1017. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Primary endpoints of the study include the maximum tolerated dose of giredestrant and as well as safety outcomes. In this trial there are 2 treatment groups: giredestrant, palbociclib and a dummy drug ( placebo ) letrozole, palbociclib and a dummy drug. This website contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. [Internet; cited 2021 June]. [9] Zhao M, Ramaswamy B. Mechanisms and therapeutic advances in the management of endocrine-resistant breast cancer. The book concludes with a focus on the applications of chiral ligands, chiral catalysts, and materials. Giredestrant works by blocking this receptor to prevent the action of oestrogen, and in the process causes the receptor to be degraded. Available from: https://clinicaltrials.gov/ct2/show/NCT04436744. This book: Explains how reconstituted by-products can best be used to radically reduce food waste Discusses the potential nutraceutical assets of recovered food waste Covers a broad range of by-product sources, such as mangos, cacao, ... Interventions, whether they be military or civilian, are descrbed in full, and techniques derived from the battlefield and world-wide hotspots in trauma —are exemplified within this book. This book examines the benefits of teaching chemistry and mathematics, and it offers new frameworks and revised syntheses of new literature surrounding the pedagogy. Bringing in a new and expert editorial board, this new edition updates existing chapters and adds 35 new ones, with topics including: opioid addiction treatments, antibody and gene therapy for cancer, blood-brain barrier, HIV treatments, ... Basel, 4 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the presentation of new and updated data on giredestrant (formerly known as GDC-9545), an investigational next generation oral selective oestrogen receptor degrader (SERD), in people with hormone receptor (HR)-positive, HER2-negative breast cancer. This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that harbor mutations in the ligand binding . Possible side effects of giredestrant include: blood clots; kidney changes; liver changes [Internet; cited 2021 June]. Abstract #577. Sara Hurvitz, and Kelly McCann consolidates today’s available information on this growing topic into one convenient resource, making it an ideal, easy-to-digest reference for practicing and trainee oncologists. Evaluation of pharmacodynamic (PD) and biologic activity in a preoperative window-of-opportunity (WOO) study of giredestrant(GDC-9545) in postmenopausal patients (pts) with estrogen receptor-positive, HER2-negative (ER+/HER2–) operable breast cancer (BC). 2h-pyrido(3,4-b)indole-2-propanol, 1-(2,6-difluoro-4-((1-(3-fluoropropyl)-3-azetidinyl)amino)phenyl)-beta,beta-difluoro-1,3,4,9-tetrahydro-3-methyl-, (1r,3r)-, 21. Giredestrant showed notable activity in the ESR1 mutant subgroup indicating that giredestrant overcomes ESR1 mutations. [12] Metcalfe C, et al. Available from: https://clinicaltrials.gov/ct2/show/NCT03916744. Evidence-based information on urine pregnancy test in Ongoing Trials from hundreds of trustworthy sources for health and social care. 3-[(1r,3r)-1-(2,6-difluoro-4-{[1-(3-fluoropropyl)azetidin-3-yl]amino}phenyl)-3-methyl-1,3,4,9-tetrahydro-2h-pyrido[3,4-b]indol-2-yl]-2,2-difluoropropan-1-ol, 6. Interventions to promote adherence to endocrine therapy among breast cancer survivors: A meta-analysis. ESR1 mutations in breast cancer. Giredestrant showed promising impact on tumour cell proliferation after ~14 days of treatment; a mean reduction of Ki67 of 78% (95% CI:72-83); 55% of tumours exhibited complete cell cycle arrest defined as Ki67 ≤2.7%. This investigational medicine has also shown efficacy regardless of ESR1 mutation status (mutations in the ESR1 gene are important mechanisms of resistance to hormone therapy).5,9,12,13Orally given, giredestrant delivers a strong clinical efficacy and safety profile and has shown superior pre-clinical potency over other SERDs in development.12,14 The oral administration of giredestrant has the potential to transform the treatment experience for patients, offering greater convenience and a less painful option compared to therapies administered via intramuscular injection. The mainstay of treatment is to block oestrogen, but the side effects of this have a very significant impact on quality of life and can greatly affect treatment adherence. Presenting both a panoramic introduction to the essential disciplines of drug discovery for novice medicinal chemists as well as a useful reference for veteran drug hunters, this book summarizes the state-of-the-art of medicinal chemistry. This HBN supersedes and replaces all versions of Health Facilities Note 30 (HFN30). Abstract P5-04-07: GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes, Crizotinib is an Orally Active, ATP-Competitive ALK and c-Met inhibitor, Anisomycin, a Protein Synthesis Inhibitor, also Interferes DNA Synthesis, Nintedanib is an Orally Active Triple Angiokinase Inhibitor for VEGFR, FGFR and PDGFR, MB710 is a Stabilizer of Oncogenic p53 Mutation Y220C. A comprehensive survey and critical analysis of today's issues in mathematics education, this volume distils research to build knowledge and capacity in the field. more about the side effects are.
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