Imfinzi

Durvalumab

Locally advanced, unresectable NSCLC in patients whose disease has not progressed following platinum-based chemoradiation therapy. 1st-line treatment of patients w/ extensive-stage small cell lung cancer (ES-SCLC) in combination w/ etoposide & either carboplatin or cisplatin. Locally advanced or metastatic biliary tract cancer (BTC) in combination w/ cisplatin & gemcitabine. Unresectable hepatocellular carcinoma (uHCC) in combination w/ tremelimumab in patients who have not received prior systemic therapy.

IV Locally advanced NSCLC 10 mg/kg infusion over 1 hr every 2 wk or 1,500 mg every 4 wk until disease progression or unacceptable toxicity. Patient weighing <30 kg Wt-based dosing at 10 mg/kg every 2 wk as monotherapy until wt increases to ≥30 kg. ES-SCLC 1,500 mg infusion over 1 hr in combination w/ chemotherapy every 3 wk for 4 cycles followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity. Patient weighing ≤30 kg Wt-based dosing at 20 mg/kg in combination w/ chemotherapy every 3 wk followed by 20 mg/kg every 4 wk as monotherapy until wt increases to >30 kg. BTC 1,500 mg infusion over 1 hr in combination w/ chemotherapy every 3 wk up to 8 cycles followed by 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity. Patient weighing ≤30 kg Wt-based dosing at 20 mg/kg in combination w/ chemotherapy every 3 wk followed by 20 mg/kg every 4 wk as monotherapy until wt increases to >30 kg. uHCC 1,500 mg at cycle 1/day 1 in combination w/ tremelimumab 300 mg as single priming dose, followed by Imfinzi 1,500 mg every 4 wk as monotherapy until disease progression or unacceptable toxicity. Patient weighing ≤30 kg Wt-based dosing at 20 mg/kg in combination w/ tremelimumab 4 mg/kg until wt is >30 kg.

Hypersensitivity.

W/hold use for severe Grade 3 immune-mediated AR. Permanently discontinue use for life-threatening Grade 4 immune-mediated AR; recurrent severe Grade 3 immune-mediated reactions that require systemic immunosuppressive treatment; or inability to reduce corticosteroid dose to ≤10 mg of prednisone or equivalent per day w/in 12 wk of corticosteroid initiation. Perform adequate evaluation to confirm or exclude alternate etiologies for suspected immune-mediated AR. W/hold use for Grade 2 & 3 AR until ≤ Grade 1 or baseline for non-immune-mediated AR. Discontinue use for Grade 4 AR w/ exception of Grade 4 lab abnormalities (decision to discontinue should be based on accompanying signs/symptoms & clinical judgment). Monitor for signs & symptoms of pneumonitis, colitis or diarrhoea, adrenal insufficiency, type 1 DM (which can present w/ diabetic ketoacidosis), hypophysitis or hypopituitarism, rash or dermatitis (including pemphigoid), immune-mediated myocarditis, other potential immune-mediated AR (eg, myasthenia gravis, myositis, polymyositis, Guillain-Barré syndrome, meningitis, noninfective cystitis, immune thrombocytopenia, pancreatitis, immune-mediated arthritis, uveitis & encephalitis) & infusion-related reactions; abnormal liver, renal & thyroid function tests prior to & periodically during treatment. Possible radiation pneumonitis in patients receiving RT to the lung. Possible SJS or TEN; iritis & other ocular inflammatory toxicities. Advise patients who experience AR affecting their ability to concentrate & react to use caution when driving or operating machinery. Severe renal & hepatic impairment. 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 woman not to breast-feed during treatment & for at least 3 mth after the last dose. Childn & adolescents <18 yr.

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

Cancer Immunotherapy

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

POM