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February 14, 2022

Can Cancer Patients Get Approved COVID Therapies? Can Cancer Patients Get Approved COVID Therapies?

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. In mid-November, Kevin Billingsley, MD, MBA, chief medical officer at Yale Cancer […]
February 14, 2022

‘Facebit’ Adds Health Monitoring to Your COVID Mask ‘Facebit’ Adds Health Monitoring to Your COVID Mask

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Millions of people wear activity monitors like Fitbits or Apple Watches that […]
February 14, 2022

Study: Hospital Discharge Safe One Day Post-Brain Tumor Resection Study: Hospital Discharge Safe One Day Post-Brain Tumor Resection

The study covered in this summary was published on ResearchSquare.com as a preprint and has not yet been peer reviewed. Key Takeaways Posterior fossa tumor resections […]
February 14, 2022

Older Age for Menopause Raises Risk for Lung Cancer Older Age for Menopause Raises Risk for Lung Cancer

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed. Key Takeaways An older age of natural menopause (ANM) appeared […]
February 14, 2022

PT as Good as Surgery for Meniscus Tears in Young Adults PT as Good as Surgery for Meniscus Tears in Young Adults

A new study published in the New England Journal of Medicine has suggested that patients in their 20s and 30s may benefit from nonoperative treatment of […]
February 14, 2022

Intrathecal Compounding Specialists, LLC – 610639 – 01/19/2022

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Kevin Schneider Recipient Title Owner Intrathecal Compounding Specialists, LLC 206A Jacob’s RunScott, LA 70583-8907United States Issuing […]
February 14, 2022

Intrathecal Compounding Specialist, LLC – 610639 – 09/15/2020

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Kevin Schneider Recipient Title Owner Intrathecal Compounding Specialist, LLC 206A Jacob’s RunScott, LA 70583-8907United States Issuing […]
February 14, 2022

FDA 正调查淋巴瘤药物Ukoniq (厄布利塞)可能增加的死亡风险

2-3-2022 FDA 药物安全通讯 English version 美国食品和药物管理局(FDA)正在调查癌症药物Ukoniq(厄布利塞)可能增加的死亡风险,该药物获准治疗两种特定类型的淋巴瘤,而淋巴瘤是影响身体免疫系统的癌症。我们确定,来自评估Ukoniq治疗相关癌症类型的临床实验初步结果表明,服用该药物的病患死亡风险可能有所增加。鉴于这一安全问题的严重性,以及该药物获批治疗的两类癌症与该临床实验研究的癌症类型之间的相似性,我们提醒病患和医疗专业人员,我们正在重新评估Ukoniq获批用途的风险和益处。 我们正在继续评估名为UNITY的临床实验结果。FDA也可能未来召开公开会议,来讨论这些结果,并探讨Ukoniq的进一步市场化。在继续审查UNITY结果的同时,我们也已经暂停招募新病患参与其他正在进行的Ukoniq临床实验。当完成审查或有了更多的可分享信息时,我们会告知我们的最终结论和建议。 医疗专业人员应当审查病患使用Ukoniq的进展情况,在有其他可用治疗方案的情况下,与患者讨论继续使用Ukoniq的风险和益处。 病患应当与您的医疗专业人员商讨Ukoniq的风险与益处,或讨论您可能关心的任何问题,包括可行的替代治疗。 Ukoniq是2021年2月批准的处方药,当成人边缘区淋巴瘤(MZL)复发,或之前至少一种特定类型的药物对其不起作用时使用。同时,针对成人的滤泡性淋巴瘤(FL)复发,或之前至少三种疗法都对其不起作用时,Ukoniq获批用于治疗这种疾病。边缘区淋巴瘤和滤泡性淋巴瘤都属于发展较慢的癌症,它们首先从被称作淋巴细胞的白血球开始出现,而淋巴细胞属于身体免疫系统。Ukoniq属于被称作PI3激酶抑制剂的一类药物,它们通过阻断标志癌细胞繁殖的异常蛋白质行为,来制止其扩散。该药物可作为片剂口服。 我们对来自UNITY的数据进行了初步审核。UNITY是一项针对慢性淋巴细胞白血病(CLL)患者的三期随机对照临床实验。通过比较接受了常规治疗的对照组患者,该实验评估Ukoniq联合一种针对CD20特定蛋白的单克隆抗体药物的情况。结果显示,和对照组相比,接受了Ukoniq和单克隆抗体药物组合治疗的病患死亡风险可能有所增加。同时,相对于对照组,接受Ukoniq和单克隆抗体药物治疗的病患遇到了更严重的不良事件。 慢性淋巴细胞白血病病患中也进行了UNITY实验,虽然其使用尚未获批,但是药物用途正在研究;然而,我们认为这些实验结果对药物获批治疗的边缘区淋巴瘤和滤泡性淋巴瘤有影响。此外,针对与Ukoniq同属PI3激酶抑制剂的其他药物进行的临床试验出现了类似的安全问题。 我们督促医疗专业人员和病患使用页面底部方框中的“联系 FDA”,向FDA安全信息与不良事件报告项目报告有关Ukoniq或其他药物的副作用 医疗专业人员、病患以及消费者可就自己感兴趣的药物或医疗专业知识注册药物安全通讯的邮件提醒。 相关信息 National Cancer Institute: Lymphoma (国家癌症研究所:淋巴癌) National Cancer Institute: Chronic Lymphocytic […]
February 14, 2022

Promising Combo for HER2-Positive Breast Cancer Brain Metastases Promising Combo for HER2-Positive Breast Cancer Brain Metastases

NEW YORK (Reuters Health) – In women with HER2 (ERBB2)-positive breast cancer brain metastases, combination therapy with pyrotinib and capecitabine elicited an intracranial response in a […]
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