商品名：Opdivo
英文通用名：Nivolumab
中文通用名：纳武单抗
靶点：PD-1
研发公司：BRISTOL MYERS SQUIBB
首次获批日期：2014年12月22日
Biologic License Application (BLA) 125554
首次获批适应症：
Opdivo is indicated for the
treatment of unresectable or metastatic melanoma and disease progression following ipilimumab
and, if BRAF V600 mutation positive, a BRAF inhibitor.
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 confirmatory trials.
适应症更新日期：
2015年9月30日、2015年10月09日、2015年11月23日、2016年1月23日、2016年5月17日、2016年11月10日、2017年2月2日、2017年4月25日
目前所有FDA批准的适应症（INDICATIONS AND USAGE）：
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody
indicated for the treatment of patients with:
BRAF V600 wild-type unresectable or metastatic melanoma, as a single
agent.
BRAF V600 mutation-positive unresectable or metastatic melanoma, as a
single agent.
This indication is approved under accelerated approval based
on progression-free survival. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in the
confirmatory trials.
Unresectable or metastatic melanoma, in combination with ipilimumab.
This indication is approved under accelerated approval based on
progression-free survival. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in the
confirmatory trials.
Metastatic non-small cell lung cancer and progression on or after platinumbased
chemotherapy. Patients with EGFR or ALK genomic tumor
aberrations should have disease progression on FDA-approved therapy for
these aberrations prior to receiving OPDIVO.
Advanced renal cell carcinoma who have received prior anti-angiogenic
therapy.
Classical Hodgkin lymphoma (adult patients) that has relapsed or
progressed after:
autologous hematopoietic stem cell transplantation (HSCT) and
brentuximab vedotin, or
3 or more lines of systemic therapy that includes autologous
HSCT.
This indication is approved under accelerated approval based on overall
response rate. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in confirmatory trials.
Recurrent or metastatic squamous cell carcinoma of the head and neck with
disease progression on or after a platinum-based therapy.
Locally advanced or metastatic urothelial carcinoma who:
• have disease progression during or following platinum-containing
chemotherapy
have disease progression within 12 months of neoadjuvant or
adjuvant treatment with platinum-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.
DOSAGE AND ADMINISTRATION：
Administer as an intravenous infusion over 60 minutes.
Unresectable or metastatic melanoma
OPDIVO 240 mg every 2 weeks.
OPDIVO with ipilimumab: OPDIVO 1 mg/kg, followed by ipilimumab
on the same day, every 3 weeks for 4 doses, then OPDIVO 240 mg
every 2 weeks.
Metastatic non-small cell lung cancer
Advanced renal cell carcinoma
Classical Hodgkin lymphoma
Recurrent or metastatic squamous cell carcinoma of the head and neck
Locally advanced or metastatic urothelial carcinoma
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Immune-mediated pneumonitis: Withhold for moderate and permanently
discontinue for severe or life-threatening pneumonitis.
Immune-mediated colitis: Withhold OPDIVO when given as a single agent
for moderate or severe and permanently discontinue for life-threatening
colitis. Withhold OPDIVO when given with ipilimumab for moderate and
permanently discontinue for severe or life-threatening colitis.
Immune-mediated hepatitis: Monitor for changes in liver function.
Withhold for moderate and permanently discontinue for severe or
life-threatening transaminase or total bilirubin elevation.
Immune-mediated endocrinopathies: Withhold for moderate or severe and
permanently discontinue for life-threatening hypophysitis. Withhold for
moderate and permanently discontinue for severe or life-threatening
adrenal insufficiency. Monitor for changes in thyroid function. Initiate
thyroid hormone replacement as needed. Monitor for hyperglycemia.
Withhold for severe and permanently discontinue for life-threatening
hyperglycemia.
Immune-mediated nephritis and renal dysfunction: Monitor for changes in
renal function. Withhold for moderate or severe and permanently
discontinue for life-threatening serum creatinine elevation.
Immune-mediated skin adverse reactions: Withhold for severe and
permanently discontinue for life-threatening rash.
Immune-mediated encephalitis: Monitor for changes in neurologic
function. Withhold for new-onset moderate to severe neurological signs or
symptoms and permanently discontinue for immune-mediated encephalitis.
Infusion reactions: Discontinue OPDIVO for severe and life-threatening
infusion reactions. Interrupt or slow the rate of infusion in patients with
mild or moderate infusion reactions.
Complications of allogeneic HSCT after OPDIVO: Monitor for hyperacute
graft-versus-host-disease (GVHD), grade 3-4 acute GVHD, steroid requiring
febrile syndrome, hepatic veno-occlusive disease, and other
immune-mediated adverse reactions. Transplant-related mortality has
occurred.
Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to a
fetus and use of effective contraception.
ADVERSE REACTIONS
Most common adverse reactions (≥20%) in patients were:
OPDIVO as a single agent: fatigue, rash, musculoskeletal pain, pruritus,
diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased
appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia.
OPDIVO with ipilimumab: fatigue, rash, diarrhea, nausea, pyrexia,
vomiting, and dyspnea.
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers
Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
—— 还有另外一个BLA ——
Biologic License Application (BLA) 125527
获批日期：2015年3月4日
首次获批适应症：
适应症更新日期：
None
INDICATIONS AND USAGE：
OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with:
unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
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.
metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
DOSAGE AND ADMINISTRATION：
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Immune-mediated adverse reactions: Administer corticosteroids based on the
severity of the reaction.
Immune-mediated pneumonitis: Withhold for moderate and permanently
discontinue for severe or life-threatening pneumonitis.
Immune-mediated colitis: Withhold for moderate or severe and
permanently discontinue for life-threatening colitis.
Immune-mediated hepatitis: Monitor for changes in liver function.
Withhold for moderate and permanently discontinue for severe or lifethreatening
transaminase or total bilirubin elevation.
Immune-mediated nephritis and renal dysfunction: Monitor for changes in
renal function. Withhold for moderate or severe and permanently
discontinue for life-threatening serum creatinine elevation.
Immune-mediated hypothyroidism and hyperthyroidism: Monitor for
changes in thyroid function. Initiate thyroid hormone replacement as
needed.
Embryofetal toxicity: Can cause fetal harm. Advise of potential risk to a
fetus and use of effective contraception.
ADVERSE REACTIONS
Most common adverse reaction (≥20%) in patients with melanoma was rash.
Most common adverse reactions (≥20%) in patients with advanced squamous
non-small cell lung cancer were fatigue, dyspnea, musculoskeletal pain,
decreased appetite, cough, nausea, and constipation.
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
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