Imfinzi

Treatment of locally advanced or metastatic urothelial carcinoma in patients whose disease has progressed during or after platinum-based chemotherapy. Treatment of locally advanced, unresectable NSCLC in patients whose disease has not progressed following platinum-based chemoradiation therapy. In combination w/ tremelimumab & platinum-based chemotherapy for 1st-line treatment of patients w/ metastatic NSCLC w/ no sensitizing epidermal growth factor receptor mutations or anaplastic lymphoma kinase genomic tumor aberrations. In combination w/ etoposide & either carboplatin or cisplatin for 1st-line treatment of patients w/ extensive-stage small cell lung cancer (ES-SCLC). In combination w/ tremelimumab in patients w/ unresectable hepatocellular carcinoma (uHCC). In combination w/ chemotherapy in patients w/ locally advanced or metastatic biliary tract cancer (BTC).

IV Infuse over 1 hr. Monotherapy: Urothelial carcinoma 10 mg/kg every 2 wk or 1,500 mg every 4 wk. Duration: As long as clinical benefit is observed or until unacceptable toxicity. Patient weighing ≤30 kg 10 mg/kg every 2 wk or 20 mg/kg every 4 wk as monotherapy until wt increases to >30 kg. Locally advanced NSCLC 10 mg/kg every 2 wk or 1,500 mg every 4 wk. Duration: Until disease progression or until unacceptable toxicity. Patient weighing ≤30 kg 10 mg/kg every 2 wk or 20 mg/kg every 4 wk as monotherapy until wt increases to >30 kg. Combination therapy: ES-SCLC 1,500 mg w/ chemotherapy every 3 wk (21 days) for 4 cycles, followed by 1,500 mg every 4 wk as monotherapy. Duration of therapy: Until disease progression or unacceptable toxicity. Patient weighing ≤30 kg 20 mg/kg. In combination w/ chemotherapy dose every 3 wk (21 days), followed by monotherapy at 20 mg/kg every 4 wk until wt increases to >30 kg. Metastatic NSCLC During chemotherapy: 1,500 mg in combination w/ tremelimumab 75 mg & platinum-based chemotherapy every 3 wk (21 days) for 4 cycles. Post-platinum chemotherapy: 1,500 mg every 4 wk as monotherapy & histology-based pemetrexed maintenance therapy every 4 wk & a 5th dose of tremelimumab w/ durvalumab dose 6 at wk 16. Duration of therapy: Until disease progression or unacceptable toxicity. Patient weighing ≤30 kg During chemotherapy: Durvalumab 20 mg/kg & tremelimumab 1 mg/kg until wt increases to >30 kg. uHCC Single tremelimumab regular interval durvalumab: 300 mg tremelimumab as single priming dose in combination w/ durvalumab 1,500 mg at cycle 1/day1, followed by durvalumab as monotherapy every 4 wk. Duration of therapy: As long as clinical benefit is observed or until unacceptable toxicity. Patient weighing ≤30 kg Durvalumab 20 mg/kg & tremelimumab 4 mg/kg until wt is >30 kg. BTC 1,500 mg w/ chemotherapy every 3 wk (21 days), followed by 1,500 every 4 wk as monotherapy. Duration of therapy: Until disease progression or unacceptable toxicity. Patient weighing ≤30 kg 20 mg/kg. In combination w/ chemotherapy dose every 3 wk (21 days), followed by monotherapy at 20 mg/kg every 4 wk until wt increases to >30 kg.

Monitor patients for signs & symptoms of pneumonitis; colitis/diarrhoea or intestinal perforation; adrenal insufficiency; type 1 DM; hypophysitis or hypopituitarism; rash or dermatitis; immune-mediated myocarditis; other immune-mediated adverse reactions (myasthenia gravis, myositis, polymyositis, immune thrombocytopenia, pancreatitis & encephalitis); infusion-related reactions. Monitor for abnormal liver & thyroid function tests prior to & periodically during treatment. Monitor for abnormal renal function tests prior to & periodically during treatment or in combination w/ tremelimumab. W/hold treatment for severe (grade 3) immune-mediated adverse reactions. Permanently discontinue for life-threatening (grade 4) immune-mediated adverse reactions, recurrent severe immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to ≤10 mg of prednisone or equiv per day w/in 12 wk of initiating corticosteroids. W/hold for grade 2 & 3 non-immune-mediated adverse reactions until ≤grade 1 or baseline. Discontinue for grade 4 non-immune-mediated adverse reactions (except for grade 4 lab abnormalities, about which the decision to discontinue should be based on accompanying clinical signs/symptoms & clinical judgment). Caution when driving or operating machinery. Not recommended during pregnancy & in women of childbearing potential not using effective contraception during treatment & for at least 3 mth after the last dose. Advise lactating women not to breast-feed during treatment & for at least 3 mth after last dose. Safety & effectiveness have not been established in childn & adolescents <18 yr.

Cough/productive cough; abdominal pain, diarrhoea; hypothyroidism; rash, pruritus; pyrexia; URTI. Pneumonitis, dysphonia; increased AST or ALT; hyperthyroidism; increased blood creatinine, dysuria; night sweats; oedema peripheral; pneumonia, oral candidiasis, dental & oral soft tissue infections, flu; myalgia; infusion related reaction. Hepatitis. Immune thrombocytopenia.

Targeted Cancer Therapy / Cancer Immunotherapy

L01FF03 - durvalumab ; Belongs to the class of PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

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