Opdivo

Monotherapy or in combination w/ ipilimumab for advanced (unresectable or metastatic) melanoma in adults & adolescents ≥12 yr. Monotherapy: Adjuvant treatment of adults & adolescents ≥12 yr w/ Stage IIB or IIC melanoma, or melanoma w/ involvement of lymph nodes or metastatic disease who have undergone complete resection. Locally advanced or metastatic NSCLC after prior chemotherapy in adults. Advanced renal cell carcinoma (RCC) after prior therapy in adults. Adult patients w/ relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant & treatment w/ brentuximab vedotin. Recurrent or metastatic squamous cell cancer of the head & neck in adults progressing on or after platinum-based therapy in adults. Adult patients w/ unresectable locally advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma after ≥2 prior systemic therapies. Adult patients w/ unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) after prior fluoropyrimidine- & platinum-based combination chemotherapy. In combination w/ ipilimumab & 2 cycles of platinum-based chemotherapy for the 1st line treatment of metastatic or recurrent NSCLC in adult patients w/ no EGFR or ALK genomic tumor mutations. In combination w/ platinum-doublet chemotherapy for the neoadjuvant treatment of adult patients w/ resectable (tumours ≥4 cm or node +ve) NSCLC. In combination w/ ipilimumab for first-line treatment of adult patients w/ unresectable malignant pleural mesothelioma (MPM). In combination w/ ipilimumab for patients w/ intermediate or poor-risk, previously untreated advanced RCC. In combination w/ cabozantinib for the 1st-line treatment of adult patients w/ advanced RCC. In combination w/ ipilimumab for 1st-line treatment of adult patients w/ unresectable advanced, recurrent or metastatic OSCC w/ tumour cell PD-L1 expression ≥1%. In combination w/ fluoropyrimidine- & platinum-based combination chemotherapy for the 1st-line treatment of adult patients w/ unresectable advanced, recurrent or metastatic OSCC w/ tumour cell PD-L1 expression ≥1%. In combination w/ fluoropyrimidine- & platinum-based chemotherapy for the treatment of patients w/ unresectable HER2 -ve advanced or metastatic gastric & gastroesophageal junction cancer or oesophageal adenocarcinoma. Ajuvant treatment of completely resected oesophageal or gastroesophageal junction cancer w/ residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy. 1st-line treatment of adult patients w/ unresectable or metastatic urothelial carcinoma in combination w/ cisplatin & gemcitabine. Adjuvant treatment of adults w/ muscle invasive urothelial carcinoma (MIUC) w/ tumor cell PD-L1 expression ≥1% who are at high risk of recurrence after undergoing radical resection of MIUC.

IV infusion Adult Monotherapy: 3 mg/kg over 30-60 min every 2 wk. Advanced melanoma & adjuvant treatment of melanoma w/ involvement of lymph nodes or metastatic disease who have undergone complete resection 3 mg/kg every 2 wk over 30-60 min. Adjuvant treatment of stage IIB or IIC melanoma who have undergone complete resection Adult & adolescent ≥12 yr & weighing at least 50 kg 240 mg every 2 wk over 30-60 min or 480 mg every 4 wk over 30-60 min. Adolescent ≥12 yr older & weighing <50 kg 3 mg/kg every 2 wk over 30-60 min or 6 mg/kg every 4 wk over 60 min. OSCC 240 mg over 30-60 min every 2 wk. Adjuvant treatment of oesophageal or GEJ cancer 240 mg over 30-60 min every 2 wk or 480 mg over 30-60 min every 4 wk. MIUC adjuvant treatment 240 mg over 30-60 min every 2 wk or 480 mg over 30-60 min every 4 wk. In combination w/ ipilimumab: Melanoma Nivolumab 1 mg/kg over 30-60 min every 3 wk for the 1st 4 doses in combination w/ ipilimumab 3 mg/kg over 30-90 min, followed by a 2nd phase in which nivolumab 3 mg/kg over 30-60 min every 2 wk. NSCLC Nivolumab 360 mg as IV infusion every 3 wk in combination w/ ipilimumab 1 mg/kg as IV infusion every 6 wk & platinum chemotherapy every 3 wk. After completion of 2 chemotherapy cycles, continue nivolumab 360 mg as IV infusion every 3 wk in combination w/ ipilimumab 1 mg/kg every 6 wk until disease progression, unacceptable toxicity, or up to 24 mth in patients w/o disease progression. MPM Nivolumab 3 mg/kg every 2 wk or 360 mg every 3 wk over 30-60 min in combination w/ ipilimumab 1 mg/kg over 30 min every 6 wk until disease progression, unacceptable toxicity, or up to 24 mth in patients w/o disease progression. RCC Nivolumab 3 mg/kg over 30-60 min every 3 wk for the 1st 4 doses in combination w/ ipilimumab 1 mg/kg over 30 min, followed by a 2nd phase in which nivolumab 3 mg/kg is administered over 30-60 min every 2 wk. Administer 1st dose of nivolumab monotherapy 3 wk following the last dose of the combination of nivolumab & ipilimumab. OSCC Nivolumab 3 mg/kg every 2 wk or nivolumab 360 mg every 3 wk over 30-60 min in combination w/ ipilimumab 1 mg/kg over 30 min every 6 wk until disease progression, unacceptable toxicity, or up to 24 mth in patients w/o disease progression. In combination w/ cabozantinib: RCC Nivolumab 240 mg every 2 wk over 30 min or 480 mg every 4 wk over 60 min in combination w/ cabozantinib 40 mg PO every day. In combination w/ chemotherapy: Neoadjuvant treatment of NSCLC Nivolumab 360 mg over 30-60 min in combination w/ platinum-based chemotherapy every 3 wk for 3 cycles. Gastric & GEJ cancer & oesophageal adenocarcinoma Nivolumab 360 mg over 30-60 min in combination w/ fluoropyrimidine- & platinum-based chemotherapy every 3 wk or nivolumab 240 mg over 30-60 min in combination w/ fluoropyrimidine- & platinum-based chemotherapy every 2 wk until disease progression or unacceptable toxicity. Max treatment duration: 24 mth. OSCC Nivolumab 240 mg every 2 wk or 480 mg every 4 wk over 30-60 min in combination w/ fluoropyrimidine- & platinum-based chemotherapy until disease progression, unacceptable toxicity, or up to 24 mth in patients w/o disease progression. 1st-line treatment of unresectable or metastatic urothelial carcinoma Nivolumab 360 mg over 30-60 min in combination w/ cisplatin & gemcitabine every 3 wk for up to 6 cycles followed by nivolumab monotherapy at 240 mg every 2 wk over 30-60 min or 480 mg every 4 wk over 30-60 min until disease progression, unacceptable toxicity, or up to 24 mth from 1st dose, whichever comes first.

Hypersensitivity.

Cancer Immunotherapy / Targeted Cancer Therapy

L01FF01 - nivolumab ; Belongs to the class of PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

POM