Patients with locally advanced (stage III) breast cancer (LABC) are characterized by a significantly worse prognosis compared to patients with primarily operable breast cancer. While neoadjuvant chemotherapy has been the first choice in this situation for several decades, recent evidence suggests that some patients may experience an extraordinary effect from neoadjuvant endocrine treatments involving aromatase inhibitors as monotherapy or in modern drug combinations.Selected LABC patients admitted for treatment will be offered combination therapy including letrozole and ribociclib. The overall goal of the project is to improve understanding of tumor responses and resistance in patients suffering from ER-positive/HER-2 negative locally advanced breast cancer, focusing on the role of the immune system including the gut microbiome.

开始日期2022-12-01

申办/合作机构

Akershus Universitetssykehus HF

[+2]

NCT03283384

/ Active, not recruiting临床2期IIT

Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.

The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.

开始日期2019-06-15

申办/合作机构

Novartis AG

[+1]

NCT04268927

/ Unknown status临床2期IIT

Extended Letrozole Regimen Co-treatment With Gonadotropin Releasing Hormone Antagonist Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Poor Responders Undergoing IVF-ET. A Randomized Controlled Trial

The object of this study is to evaluate the efficacy of extended letrozole co-treatment with GnRH-antagonist protocol in ovarian stimulation of poor responder patients undergoing IVF-ET.

开始日期2018-04-01

申办/合作机构

Cairo University

100 项与来曲唑/琥珀酸瑞博西尼相关的临床结果

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100 项与来曲唑/琥珀酸瑞博西尼相关的转化医学

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100 项与来曲唑/琥珀酸瑞博西尼相关的专利（医药）

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项与来曲唑/琥珀酸瑞博西尼相关的文献（医药）

2023-09-01·Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners

Toxic hepatitis in metastatic breast cancer patient using ribociclib and denosumab

Article

作者: Aktürk Esen, Selin ; Köş, Fahriye Tuğba ; Bayram, Doğan ; Uçar, Gökhan

Introduction:

Hepatotoxicity is observed due to cyclin-dependent kinase (CDK4/6) inhibitors used to treat hormone receptor-positive metastatic breast cancer. However, it should not be ignored that denosumab may be hepatotoxic, although it is rare.

Case Report:

A 73-year-old female patient with breast cancer with axillary lymph node, adrenal gland and bone metastases was started on ribociclib letrozole and denosumab treatment. Ribociclib treatment was discontinued due to grade 4 hepatotoxicity during treatment, but liver function tests did not decrease. After discontinuation of denosumab treatment, alanine aminotransferase and aspartate aminotransferase values regressed to baseline values.

Management and Outcome:

Despite the discontinuation of ribociclib treatment, other causes of liver toxicity were investigated due to persistence of hepatic transaminases and elevation. Autoimmune hepatitis markers were negative. Hepatobiliary USG did not reveal any pathological findings except hepatosteatosis. Liver biopsy was performed to determine the etiology. Pathology result was compatible with acute hepatocellular damage (in favor of toxic hepatitis). A decrease in liver values was detected after discontinuation of denosumab treatment.

Discussion:

Although cases with improvement in liver enzymes have been reported after discontinuation of ribociclib, no improvement in hepatotoxicity was observed in our case. Since the liver biopsy was toxic hepatitis, it was thought that other drugs used by the patient might cause this toxicity, and a significant decrease was observed in liver values after discontinuation of denosumab. Denosumab-induced liver toxicity is very rare, and there are only a limited number of cases in the literature.

项与来曲唑/琥珀酸瑞博西尼相关的新闻（医药）

2025-08-29

·EINPresswire

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. 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Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. 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上市批准

2024-09-17

·fda

FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer

On September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack (Kisqali Femara Co-Pack, Novartis Pharmaceuticals Corporation) for the same indication. Full prescribing information for Kisqali and Kisqali Femara Co-Pack will be posted on Drugs@FDA. Efficacy and Safety Efficacy of ribociclib with a non-steroidal aromatase inhibitor (NSAI) was evaluated in NATALEE (NCT03701334), a randomized, open-label, multicenter trial in 5101 adults with HR-positive, HER2-negative early breast cancer. The trial included patients with any lymph node involvement (excluding microscopic nodal involvement), or if there was no nodal involvement, either tumor size > 5 cm, or tumor size 2 to 5 cm with either Grade 2 (and high genomic risk or Ki67 ≥ 20%) or Grade 3. Participants were randomized (1:1) to receive ribociclib (400 mg) + NSAI or NSAI alone; patients could receive goserelin as indicated. Randomization was stratified by anatomic stage, prior chemotherapy (neoadjuvant versus adjuvant), menopausal status (premenopausal and males versus postmenopausal) and region (North America/Western Europe/Oceania versus rest of the world). The main efficacy outcome measure was invasive disease-free survival (iDFS). iDFS was defined as randomization to the first occurrence of the following: local or regional invasive breast recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, or secondary primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). A statistically significant improvement in iDFS was observed in the intent-to-treat patient population at an interim analysis. Efficacy results at the final iDFS analysis showed that iDFS at 36 months was 90.7% (95% CI: 89.3, 91.8) in the ribociclib + NSAI arm and 87.6% (95% CI: 86.1, 88.9) in the NSAI arm, with a hazard ratio of 0.749 (95% CI: 0.628, 0.892). At the time of the iDFS final analysis, OS was immature. The adverse reactions observed on the NATALEE trial were consistent with the current safety profile for ribociclib in combination with an NSAI. The prescribing information provides additional safety information. In the adjuvant treatment setting, the recommended ribociclib dose is 400 mg (two 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles. Refer to the prescribing information for the recommended dosage of the aromatase inhibitor. Kisqali has newly updated storage conditions. Kisqali should now be refrigerated until dispensed to patients. After dispensing, healthcare providers should advise patients to store Kisqali at room temperature for up to 2 months. Expedited Programs This review used the Assessment Aid, a voluntary submission from the Applicant to facilitate the FDA’s assessment. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Follow the Oncology Center of Excellence on X: @FDAOncology.

临床结果上市批准

2024-09-17

·fda.gov

FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer

On September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack (Kisqali Femara Co-Pack, Novartis Pharmaceuticals Corporation) for the same indication. Full prescribing information for Kisqali and Kisqali Femara Co-Pack will be posted on Drugs@FDA. Efficacy of ribociclib with a non-steroidal aromatase inhibitor (NSAI) was evaluated in NATALEE (NCT03701334), a randomized, open-label, multicenter trial in 5101 adults with HR-positive, HER2-negative early breast cancer. The trial included patients with any lymph node involvement (excluding microscopic nodal involvement), or if there was no nodal involvement, either tumor size > 5 cm, or tumor size 2 to 5 cm with either Grade 2 (and high genomic risk or Ki67 ≥ 20%) or Grade 3. Participants were randomized (1:1) to receive ribociclib (400 mg) + NSAI or NSAI alone; patients could receive goserelin as indicated. Randomization was stratified by anatomic stage, prior chemotherapy (neoadjuvant versus adjuvant), menopausal status (premenopausal and males versus postmenopausal) and region (North America/Western Europe/Oceania versus rest of the world). The main efficacy outcome measure was invasive disease-free survival (iDFS). iDFS was defined as randomization to the first occurrence of the following: local or regional invasive breast recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, or secondary primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). A statistically significant improvement in iDFS was observed in the intent-to-treat patient population at an interim analysis. Efficacy results at the final iDFS analysis showed that iDFS at 36 months was 90.7% (95% CI: 89.3, 91.8) in the ribociclib + NSAI arm and 87.6% (95% CI: 86.1, 88.9) in the NSAI arm, with a hazard ratio of 0.749 (95% CI: 0.628, 0.892). At the time of the iDFS final analysis, OS was immature. The adverse reactions observed on the NATALEE trial were consistent with the current safety profile for ribociclib in combination with an NSAI. The prescribing information provides additional safety information. In the adjuvant treatment setting, the recommended ribociclib dose is 400 mg (two 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles. Refer to the prescribing information for the recommended dosage of the aromatase inhibitor. Kisqali has newly updated storage conditions. Kisqali should now be refrigerated until dispensed to patients. After dispensing, healthcare providers should advise patients to store Kisqali at room temperature for up to 2 months. This review used the Assessment Aid, a voluntary submission from the Applicant to facilitate the FDA’s assessment. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Follow the Oncology Center of Excellence on X: @FDAOncologyExternal Link Disclaimer. Content current as of: 09/17/2024 Regulated Product(s) Drugs 09/17/2024 Drugs Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description

临床结果上市批准加速审批

100 项与来曲唑/琥珀酸瑞博西尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	-

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适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2017-05-04

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适应症	最高研发状态	国家/地区	公司	日期
晚期乳腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	比利时	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	巴西	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	捷克	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	丹麦	Novartis Pharmaceuticals Corp.	2013-12-17
晚期乳腺癌	临床3期	芬兰	Novartis Pharmaceuticals Corp.	2013-12-17

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01958021 (ML-2 \| MONALEESA-2, CTgov)	临床3期	转移性乳腺癌 \| 晚期乳腺癌 \| HR阳性/HER2阴性乳腺癌	668	Placebo+Letrozole	壓鑰鹽鹹憲蓋繭窪夢鹹(鹹衊齋鹽膚獵選製廠範) = 衊構糧廠壓窪觸範範衊獵廠淵築鹽簾鑰夢糧鏇 (淵製廠鹽壓網繭衊齋積, 積糧齋鬱餘淵構襯壓夢 ~ 繭獵觸積繭夢醖夢衊鏇) 更多	-	2017-05-12