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Keytruda(pembrolizumab)被批准治療晚期非小細胞肺癌
2014年9月4日,美国食品药品监督管理局(FDA)授权加速批准Keytruda(pembrolizumab)为治疗对其他不再反应的晚期或不可切除黑色素瘤。2015年10月2日,Keytruda被批准用于治疗晚期（转移性）非小细胞肺癌（NSCLC），适用于其它药物治疗后疾病进展及肿瘤表达一种叫 PD-L1 蛋白的患者。
Keytruda(pembrolizumab)注射剂
肺癌
在针对NSCLC患者的临床试验中表明，使用keytruda治疗获得的总体应答率为41%。
黑色素瘤
未接受过Ipilimumab治疗的黑色素瘤：每三周注射一次Keytruda获得的总体应答率（ORR）为33%；每两周注射一次keytruda获得的总体应答率（ORR）为34%；既往使用过Ipilimumab难以治疗的黑色素瘤：keytruda按每公斤体重使用剂量2mg/kg，每三周注射一次获得的总体应答率为21%；按每公斤体重使用剂量10mg/kg，每三周注射一次获得的总体应答率为25%。
Keytruda 通过作用于 PD-1/PD-L1（人体免疫细胞及一些癌症细胞上发现的蛋白）细胞通路而起作用。通过阻断这一通路，Keytruda 可以帮助人体免疫系统抗击癌症细胞。
Keytruda是阻断被称为PD-1的细胞通路第一个被批准的药物，它限制机体免疫系统攻击黑色素瘤细胞的。Keytruda是意向用于以下治疗：用伊匹单抗[ipilimumab]，一种类型免疫治疗。对黑色素瘤患者其肿瘤表达一种基因突变被称为BRAF V600，Keytruda是意向为用伊匹单抗治疗后使用和一种BRAF抑制剂，一种治疗that阻断BRAF基因突变的活性。
Keytruda的最常见副作用是疲劳，咳嗽，恶心，皮肤瘙痒，皮疹，食欲减低，便秘，关节痛和腹泻。Keytruda 也有可能引起严重副作用，主要由 Keytruda 对免疫系统的作用导致（称「免疫介导的副作用」）。在晚期黑色素瘤参加者中，严重免疫介导的副作用涉及健康器官，包括肺，结肠，激素-生成腺体和肝脏，不常见发生。
对以下任何不给Keytruda：
●2级肺炎
●2或3级结肠炎
●症状性垂体炎
●2级肾炎
●3级 甲状腺功能亢进
●谷草转氨酶(AST)或丙氨酸氨基转移酶(ALT)大于3和直至5倍正常上限(ULN)或总胆红素大于1.5和直至ULN3倍。
●任何其他严重或3级治疗-相关不良事件
在患者其不良反应恢复至0-1级恢复 KEYTRUDA.
对以下任何永远终止 KEYTRUDA：
●任何危及生命不良事件
●3或4级肺炎
●3或4级肾炎
●AST或ALT大于5倍ULN或总胆红素大于3倍ULN
●对有肝转移患者开始治疗有2级AST或ALT，如AST或ALT增加相对于基线大于或等于50%和持续共至少1周
●3或4级输注-相关反应
●12周内不能减低皮质激素剂量至10 mg或低于泼尼松[prednisone]或等价物每天
●持续2或3级不良反应KEYTRUDA末次剂量后12周内不恢复至0-1级
●任何严重或3级治疗-相关不良事件再发生
完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287
Keytruda (Pembrolizumab for Injection)
KEYTRUDA is a prescription medicine used to treat:
•a kind of skin cancer called melanoma. It may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma).
•a kind of lung cancer called non–small cell lung cancer (NSCLC). ◦It may be used alone as your first treatment when your lung cancer has spread (advanced NSCLC) and tests positive for “PD-L1” and your tumor does not have an abnormal “EGFR” or “ALK” gene.
◦It may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and your lung cancer tests positive for “PD-L1” and, if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
•a kind of cancer called head and neck squamous cell cancer (HNSCC). It may be used when your HNSCC has returned or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
•a kind of cancer called classical Hodgkin lymphoma (cHL). KEYTRUDA may be used for cHL in adults and children when you have tried a treatment and it did not work or when your cHL has returned after you received 3 or more types of treatment.
•a kind of bladder or urinary tract cancer when it has spread or cannot be removed by surgery (advanced urothelial cancer) and you are not able to receive chemotherapy that contains a medicine called cisplatin, or you have received chemotherapy that contains platinum, and it did not work or is no longer working.
•a kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor. KEYTRUDA may be used in adults and children to treat: ◦cancer that has spread or cannot be removed by surgery (advanced cancer), and
◦has progressed following treatment, and you have no satisfactory treatment options, or
◦you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.
It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).
PD-L1 = programmed death ligand 1;
EGFR = epidermal growth factor receptor;
ALK = anaplastic lymphoma kinase.
Important Safety Information About KEYTRUDA® (pembrolizumab)
KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
Call or see your doctor right away if you develop any symptoms of the following problems or these symptoms get worse:
Lung problems (pneumonitis). Symptoms of pneumonitis may include shortness of breath, chest pain, or new or worse cough.
Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or 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, nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine, feeling less hungry than usual, or bleeding or bruising more easily than normal.
Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include rapid heartbeat, weight loss or weight gain, increased sweating, feeling more hungry or thirsty, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, or headaches that will not go away or unusual headache.
Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include change in the amount or color of your urine.
Skin problems. Signs of skin problems may include rash, itching, blisters, peeling or skin sores, or painful sores or ulcers in your mouth or in your nose, throat, or genital area.
Problems in other organs. Signs of these problems may include changes in eyesight, severe or persistent muscle or joint pains, severe muscle weakness, or low red blood cells (anemia), shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis).
Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, shortness of breath or wheezing, itching or rash, flushing, dizziness, fever, or feeling like passing out.
Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection if they are treated with KEYTRUDA.
Complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with KEYTRUDA. These complications can be severe and can lead to death. Your doctor will monitor you for signs of complications if you are an allogeneic stem cell transplant recipient.
Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines. Your doctor may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects.
Before you receive KEYTRUDA, tell your doctor if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung or breathing problems; have liver problems; or have any other medical problems.
If you are pregnant or plan to become pregnant, tell your doctor. KEYTRUDA can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your doctor right away if you become pregnant during treatment with KEYTRUDA.
If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if KEYTRUDA passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA and for 4 months after your final dose of KEYTRUDA.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Common side effects of KEYTRUDA include feeling tired, itching, diarrhea, decreased appetite, rash, fever, cough, shortness of breath, pain in muscles, bones or joints, constipation, and nausea.
In children, feeling tired, vomiting and stomach-area (abdominal) pain, and increased levels of liver enzymes and decreased levels of salt (sodium) in the blood are more common than in adults.
These are not all the possible side effects of KEYTRUDA. |
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