[{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eli Lilly's Abemaciclib Improves OS In Combination With Tamoxifen In HR-Positive, HER2-Negative Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Kisqali Receives Highest Rating of any CDK4\/6 Inhibitor on the ESMO Magnitude of Clinical Benefit Scale","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"September 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Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda\u2019s Breast Cancer Treatment Approved in Scotland","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Peptide","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Initiates Phase 1\/2 Clinical Study of DARE-VVA1, Intravaginal Tamoxifen for the Treatment of Vulvar and Vaginal Atrophy","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data from Verzenio\u00ae (abemaciclib) monarchE Study to Be Featured in ESMO Virtual Plenary","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Agilent Technology Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA 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Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces Positive Topline Results from DARE-VVA1 Phase 1\/2 Clinical Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Diaccurate","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diaccurate Announces Updated Data on its Novel PAM Pathway Inhibitor DIACC3010 in Patients with ER+ HER2- Metastatic Breast Cancer to be Presented at AACR 2023","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"DARA BIOSCIENCES","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces FDA Clearance of Investigational New Drug (IND) Application for DARE-VVA1, a Novel Intravaginal Formulation of Tamoxifen for Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy Associated with Menopause","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for NCGC00024928-06
DARE-VVA1 (tamoxifen) is a small molecule vaginal insert acting as an Estrogen receptor modulator, which is being investigated for the treatment of moderate to severe dyspareunia.
DIACC3010 was well tolerated in monotherapy and potential biomarkers of pharmacological activity were seen in peripheral blood mononuclear cells and tumor tissues.
DARE-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration with the potential to be a first-in-category treatment of VVA for women with or at-risk of HR+ breast cancer.
Verzenio® abemaciclib is a targeted treatment known as a CDK4/6 inhibitor. Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies).
Based on results, Verzenio may require dose modification. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. Advise patients of potential risk to a fetus and to use effective contraception.
Data from monarchE study for Verzenio® (abemaciclib), CDK)4/6 inhibitor used in combination with endocrine therapy used in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2) high risk early breast cancer abemaciclib).
DARE-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration with the potential to be a first-in-category treatment of VVA for women with or at-risk of HR+ breast cancer.
The Scottish Medicines Consortium has accepted Takeda’s PROSTAP 3 DCS (leuprorelin acetate) treatment for use in patients with early and advanced breast cancer, which is the most common cancer in women globally.
Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up.
KISQALI® is the first CDK4/6 inhibitor to show statistically significant improvement in overall survival (key secondary endpoint) in advanced breast cancer in pre- and perimenopausal women.
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