PD-1 / PD-L1药物信息更新 | Opdivo（2017-08-01，英文版）

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

OPDIVO 240 mg every 2 weeks.

Advanced renal cell carcinoma

OPDIVO 240 mg every 2 weeks.

Classical Hodgkin lymphoma

OPDIVO 3 mg/kg every 2 weeks.

Recurrent or metastatic squamous cell carcinoma of the head and neck

OPDIVO 3 mg/kg every 2 weeks.

Locally advanced or metastatic urothelial carcinoma

OPDIVO 240 mg every 2 weeks

DOSAGE FORMS AND STRENGTHS

Injection: 40 mg/4 mL and 100 mg/10 mL solution in a single-dose vial.

CONTRAINDICATIONS

None.

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

Lactation: Discontinue breastfeeding.

—— 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：

OPDIVO is indicated for treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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：

Administer 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks.

DOSAGE FORMS AND STRENGTHS

Injection: 40 mg/4 mL and 100 mg/10 mL solution in a single-use vial.

CONTRAINDICATIONS

None.

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

Lactation: Discontinue breastfeeding.

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

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