Four Recent FDA Drug Approvals: Myovant, Integrum, AstraZeneca and Ridgeback


2020-12-23 03:00:13 BioSpace


The U.S. Food and Drug Administration (FDA) has approved several drugs and medical devices in the last week. Here’s a look. Myovant’s Orgovyx for Advanced Prostate Cancer On December 18, the FDA approved Myovant Sciences’ Orgovyx (relugolix) for treatment of adults with advanced prostate cancer. The drug was granted Priority Review and is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. The approval was based on data from the Phase III HERO trial. “I am enormously pleased by the approval of Orgonovyx and believe it has the potential to usher in a new standard of care for men with prostate cancer requiring androgen deprivation therapy,” said Neal Shore, medical director of the Carolina Urologic Research Center and HERO program steering committee member. “For the first time, we now have a once-daily oral treatment that effectively and rapidly suppresses testosterone, with a safety analysis showing a lower incidence of major adverse cardiovascular events compared to leuprolide injections, the current standard of care, as evaluated in the Phase III HERO study.” Integrum’s OPRA Implant System for Above-the-Knee Amputations The FDA also approved on December 17, Sweden-based Integrum AB’s OPRA Implant System, a class III medical device. It is an American Premarket Approval process. A typical leg prosthesis uses a specially-fitted, cup-like shell (socket) that fits over the remaining part of the patient’s leg. But not all patients have a long enough residual limb to properly fit a socket prosthesis or may have scarring, pain or other conditions that prevent it. The OPRA Implant System is surgically anchored and integrated into the patient’s remaining thigh bone. “Today’s approval of the OPRA Implant System expands options for prostheses for individuals who have had above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses,” said Capt. Raquel Peat, director of the FDA’s Center for Devices and Radiological Health’s Office of Orthopedic Devices. “Prostheses can help people who have lost a leg due to trauma or cancer to regain mobility and to more easily participate in everyday activities.” AstraZeneca’s Tagrisso for EGFRm Non-Small Cell Lung Cancer On December 21, the FDA approved AstraZeneca’s Tagrisso (Osimertinib) for adjuvant treatment of adults with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent. The drug is indicated for EGFRm patients whose tumors have exon 19 deletion or exon 21 L858R mutations. The approval was made under the agency’s Real-Time Oncology Review (RTOR) pilot program. Five other countries participated in a concurrent submission and review process via FDA’s Project Orbis. “For the first time, a targeted, biomarker-driven treatment option is available to patients in the US with early-stage EGFR-mutated lung cancer,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca. “This approval dispels the notion that treatment is over after surgery and chemotherapy, as the ADAURA results show that Tagrisso can dramatically change the course of this disease. We remain committed to treating cancer patients earlier, when they may still have a chance of being cured.” Ridgeback Therapeutics’ Ebanga Antibody Treatment for Ebola On December 21, the FDA approved Ridgeback Therapeutics’ Ebanga (ansuvimab-zykl) for treatment of Zaire ebolavirus infection in adults and children. Ebanga is a human monoclonal antibody that blocks binding of the Ebolavirus to the cell receptor, preventing its entry into the cell. Zaire ebolavirus is one of four Ebolavirus species that can cause the potentially fatal disease. The therapy was evaluated in the PALM trial during the Ebola outbreak in the Democratic Republic of the Congo (DRC) in 2018-2019. The trial was led by the U.S. National Institutes of Health and the DRC’s Institut National de Recherche Biomedicale. In the PALM Trial, Ebanga was evaluated in 174 participants, 120 adults and 54 children, with confirmed Ebolavirus infection. They received an IV of a single 50 mg/kg infusion; 168 participants, 135 adults and 33 children, received an investigational control. The primary efficacy endpoint was 28-day mortality. Of the 174 patients receiving Ebanga, 35.1% died after 28 days, compared to 49.4% of the 168 patients who received a control. Most Read Today
美国食品和药物管理局(FDA)在最近一周批准了几种药物和医疗器械。给你看看。 Myovant Orgovyx治疗晚期前列腺癌 12月18号,FDA批准Myovant Sciences公司的Orgovyx(relugolix)用于治疗成人晚期前列腺癌。该药获优先审评,是首个也是唯一一个用于晚期前列腺癌男性的口服促性腺激素释放激素(GnRH)受体拮抗剂。批准是基于HERO三期试验的数据。 卡罗莱纳州泌尿学研究中心医学主任兼HERO项目指导委员会成员尼尔·肖尔说:“我对Orgonovyx的批准感到非常高兴,并相信它有潜力为需要雄激素剥夺疗法的前列腺癌男性开创一种新的护理标准。“我们现在第一次有了一种每日一次的口服治疗,它能有效和迅速地抑制睾酮,安全性分析显示,与目前的护理标准亮丙瑞林注射相比,主要不良心血管事件的发生率更低,正如III期HERO研究所评估的那样。” Integrum公司的OPRA植入系统用于膝上截肢 FDA还于12月17号批准了瑞典Integrum AB公司的OPRA植入系统,这是一种III类医疗设备。这是一个美国的上市前审批程序。典型的假肢使用一个特殊的,杯状的外壳(插口),它套在病人腿的剩余部分上。但并不是所有的患者都有足够长的残肢来合适地安装假肢,或者可能有疤痕,疼痛或其他情况阻止它。OPRA植入系统通过手术锚定并整合到患者剩余的大腿骨中。 FDA装置和放射健康中心矫形装置办公室主任拉奎尔·皮特上尉说:“今天OPRA植入系统的批准扩大了膝上截肢患者的假体选择范围,可以帮助那些已经或可能有康复问题,无法从现有的假肢中获益的人。”“假肢可以帮助那些因创伤或癌症失去一条腿的人恢复行动能力,更容易地参与日常活动。” 阿斯利康Tagrisso治疗EGFRm非小细胞肺癌 12月21号,FDA批准阿斯利康的Tagrisso(奥西莫替尼)用于成人早期表皮生长因子受体突变(EGFRm)非小细胞肺癌(NSCLC)切除后的辅助治疗。该药物适用于肿瘤有外显子19缺失或外显子21 L858R突变的EGFRm患者。这项批准是在该机构的实时肿瘤学审查(RTOR)试点计划下做出的。另外五个国家通过FDA的Orbis项目参与了同时提交和审查程序。 阿斯利康公司肿瘤业务部执行副总裁Dave Fredrickson说:“美国的早期EGFR突变肺癌患者首次获得了靶向的,生物标志物驱动的治疗选择。“这项批准消除了手术和化疗后治疗就结束的观念,因为ADAURA的结果表明Tagrisso可以显著改变这种疾病的进程。我们仍致力于尽早治疗癌症患者,因为他们仍有机会被治愈。“ Ridgeback Therapeutics公司的Ebanga抗体治疗埃博拉 12月21号,FDA批准Ridgeback Therapeutics公司的Ebanga(安苏维单抗-ZYKL)用于治疗成人和儿童的扎伊尔埃博拉病毒感染。Ebanga是一种人类单克隆抗体,它能阻断埃博拉病毒与细胞受体的结合,阻止其进入细胞。扎伊尔埃博拉病毒是四种可能导致这种潜在致命疾病的埃博拉病毒之一。该疗法在2018~2019年刚果民主共和国(金)埃博拉疫情爆发期间的PALM试验中进行了评估。这项试验是由美国国立卫生研究院和刚果民主共和国国家生物医学研究所领导的。 在PALM试验中,Ebanga在174名参与者(120名成人和54名儿童)中进行了评估,这些参与者被证实感染了埃博拉病毒。他们接受单次静脉注射50毫克/千克;168名参与者(135名成人和33名儿童)接受了调查对照。主要疗效终点为28天死亡率。在174名接受Ebanga治疗的患者中,35.1%在28天后死亡,而在168名接受对照治疗的患者中,这一比例为49.4%。 今天阅读最多的