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：
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
（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.
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
CONTRAINDICATIONS
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.
