2015年3月4日，美国食品和药品监管局(FDA)扩展批准使用Opdivo(nivolumab)治疗有晚期(转移)鳞状细胞非小细胞肺癌(NSCLC)用基于铂化疗或后有进展患者。
在美国肺癌是是癌症死亡的领先原因，在2014年有估计224,210例新诊断和159,260例死亡。肺癌的最常见型，NSCLC影响7/8肺癌患者，当在肺的细胞中癌形成时发生。
Opdivo通过抑制细胞通路被称为细胞上PD-1蛋白它阻断机体免疫系统攻击癌细胞起作用。Opdivo是意向为以前曾用基于铂化疗治疗患者。
FDA的药品评价和研究中心内血液学和肿瘤学产品室主任Richard Pazdur，M.D.说：“当2014年12月这个临床试验结果首次可得到时，FDA主动与公司工作有利于这个早期递交和审评，”“这个批准将为患者和卫生保健提供者提供伴随Opdivo生存获益的知识和将有助于指导患者医护和未来肺癌试验。”
在一项272例参加者，其中135例接受Opdivo和137例接受多西紫杉醇的随机化试验确定Opdivo治疗鳞状NSCLC的疗效。这个试验被设计测量开始治疗后参加者生存(总生存)的时间量。接受Opdivo参加者生存比接受多西紫杉醇[docetaxel]参加者平均较长3.2个月。
Opdivo治疗鳞状NSCLC的安全性和疗效被一项117例接受一个基于铂治疗和至少另外一种全身方案后进展的参加者单-臂试验支持。研究被设计测量客观反应率(ORR)，或经历肿瘤部分皱缩或完全消失参加者百分率。结果显示15%参加者经历ORR，其中59%有反应时间 6个月或更长。
Opdivo的最常见副作用是疲劳，气短，肌肉骨骼痛，食欲减退，咳嗽，恶心和便秘。最常见严重副作用是严重免疫介导副作用涉及健康器官，包括肺，结肠，肝，肾和激素-生成腺。
在FDA的优先审评程序下审评Opdivo对鳞状NSCLC，程序对治疗严重情况和，如被批准，某种严重情况的治疗中安全性或有效性提供显著改善的药物提供加快审评，Opdivo正在被批准比处方药用户收费目标日期2015年6月22日，即监管局计划完成申请审评日期提前大于三个月个月。
FDA以前批准Opdivo治疗患者对其他药物不再反应有不能用手术切除或转移黑色素瘤。
Opdivo由总部在新泽西Princeton 的Bristol-Myers Squibb公司上市。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436534.htm
IMPORTANT SAFETY INFORMATION ABOUT OPDIVO®(nivolumab)
OPDIVO® (nivolumab) is a medicine that may treat your melanoma by helping to work with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.
Serious side effects may include:
•Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath.
•Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness.
•Liver problems (hepatitis). Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach-area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruise more easily than normal; and feeling less hungry than usual.
•Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite.
•Hormone gland problems (especially the thyroid, pituitary, and glands). Signs and symptoms that your hormone glands are not working properly may include: headaches that will not go away or unusual headaches; extreme tiredness, weight gain or weight loss; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; dizziness or fainting; hair loss; feeling cold; constipation; and voice gets deeper.
•Problems in other organs. Signs of these problems include: rash; changes in eyesight; severe or persistent muscle or joint pains; and severe muscle weakness.
Getting medical treatment right away may keep these problems from becoming more serious.
Your doctor will check you for these problems |
