PD-1 / PD-L1药物信息更新 | Keytruda（2017-07-30，英文版）

2017年07月30日 14:41 医药研发社交平台

商品名：Keytruda

英文通用名：Pembrolizumab

中文通用名：派姆单抗

靶点：PD-1

研发公司：MERCK SHARP DOHME

首次获批日期：2014年9月4日

首次获批适应症：

patients with muesectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

适应症更新日期：

2015年10月2日、2015年12月18日、2016年8月5日、2016年10月24日、2017年3月14日、2017年5月10日、2017年5月18日、2017年5月23日

目前所有FDA批准的适应症（INDICATIONS AND USAGE）：

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in:

（1）Melanoma

for the treatment of patients with unresectable or metastatic melanoma.

（2）Non-Small Cell Lung Cancer (NSCLC)

as a single agent for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression [(Tumor Proportion Score (TPS) ≥50%)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
in combination with pemetrexed and carboplatin, as first-line treatment of patients with metastatic nonsquamous NSCLC.

This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

（3）Head and Neck Squamous Cell Cancer (HNSCC)

for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

（4）Classical Hodgkin Lymphoma (cHL)

for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

（5）Urothelial Carcinoma

for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

（6）Microsatellite Instability-High Cancer

for the treatment of adult and pediatric patients with unresectable or

metastatic, microsatellite instability-high (MSI-H) or mismatch repair

deficient

solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor

response rate and durability of response. Continued approval for this

indication may be contingent upon verification and description of clinical

benefit in the confirmatory trials.

Limitation of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

DOSAGE AND ADMINISTRATION：

Melanoma: 200 mg every 3 weeks.
NSCLC: 200 mg every 3 weeks.
HNSCC: 200 mg every 3 weeks.
cHL: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics.
Urothelial Carcinoma: 200 mg every 3 weeks.
MSI-H Cancer: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for children.

Administer KEYTRUDA as an intravenous infusion over 30 minutes.

DOSAGE FORMS AND STRENGTHS

For injection: 50 mg lyophilized powder in single-dose vial for reconstitution
Injection: 100 mg/4 mL (25 mg/mL) solution in a single-dose vial

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Immune-mediated Pneumonitis: Withhold for moderate, and permanently discontinue for severe, life-threatening or recurrent moderate pneumonitis.
Immune-mediated Colitis: Withhold for moderate or severe, and permanently discontinue for life-threatening colitis.
Immune-mediated Hepatitis: Monitor for changes in hepatic function. Based on severity of liver enzyme elevations, withhold or discontinue.
Immune-mediated Endocrinopathies:

Hypophysitis: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening hypophysitis.
Thyroid disorders: Monitor for changes in thyroid function. Withhold or permanently discontinue for severe or lifethreatening hyperthyroidism.
Type 1 diabetes mellitus: Monitor for hyperglycemia. Withhold KEYTRUDA in cases of severe hyperglycemia.

Immune-mediated nephritis: Monitor for changes in renal function. Withhold for moderate, and permanently discontinue for severe or life-threatening nephritis.
Infusion-related reactions: Stop infusion and permanently discontinue KEYTRUDA for severe or life-threatening infusion reactions.
Complications of allogeneic HSCT after KEYTRUDA: Monitor for hepatic veno-occlusive disease, grade 3-4 acute GVHD including hyperacute GVHD, steroid-requiring febrile syndrome, and other immune-mediated adverse reactions. Transplant-related mortality has occurred.
Embryofetal toxicity: KEYTRUDA can cause fetal harm. Advise female of reproductive potential of the potential risk to a fetus.

ADVERSE REACTIONS

Most common adverse reactions (reported in ≥20% of patients) were fatigue, pruritus, diarrhea, decreased appetite, rash, pyrexia, cough, dyspnea, musculoskeletal pain, constipation, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877- 888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Lactation: Discontinue nursing or discontinue KEYTRUDA.

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参考资料及重要声明：

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