Keytruda

Unresectable or metastatic melanoma. Adjuvant treatment in adult & ped patients ≥12 yr w/ stage IIB, IIC or III melanoma who have undergone complete resection. 1st-line treatment in patients w/ metastatic NSCLC w/ no EGFR or ALK genomic tumor aberrations in combination w/ pemetrexed & platinum chemotherapy; w/ metastatic squamous NSCLC in combination w/ carboplatin & either paclitaxel or nab-paclitaxel. Monotherapy for 1st-line treatment in patients w/ metastatic NSCLC whose tumors express PD-L1 w/ ≥50% tumor proportion score as determined by a validated test w/ no EGFR or ALK genomic tumor aberrations. Monotherapy for locally advanced or metastatic NSCLC whose tumors express PD-L1 as determined by a validated test & who have received platinum-containing chemotherapy. Patients w/ resectable stage II, IIIA or IIIB (T3-4N2) NSCLC in combination w/ platinum-containing chemotherapy as neoadjuvant treatment & then continued as monotherapy as adjuvant treatment. Monotherapy as adjuvant treatment following resection & platinum-based chemotherapy in adults w/ stage IB (T2a ≥4 cm), II or IIIA NSCLC. Monotherapy or in combination w/ platinum & 5-fluorouracil chemotherapy for 1st-line treatment in patients w/ metastatic or unresectable recurrent head & neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 w/ combined +ve score (CPS) ≥1. Adult & ped patients ≥3 yr w/ relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least 2 prior therapies when ASCT is not a treatment option. Locally advanced or metastatic urothelial carcinoma whose tumours express PD-L1 w/ CPS ≥10 as determined by a validated test & who are not eligible for cisplatin-containing chemotherapy; who have received prior platinum-containing chemotherapy. In combination w/ fluoropyrimidine- & platinum-containing chemotherapy for 1st-line treatment in patients w/ locally advanced unresectable or metastatic HER2 -ve gastric or gastroesophageal junction (GEJ) adenocarcinoma; w/ locally advance or metastatic carcinoma of esophagus or HER2 -ve GEJ adenocarcinoma that is not amenable to surgical resection or definitive chemoradiation; in combination w/ trastuzumab, fluoropyrimidine & platinum-containing chemotherapy for 1st-line treatment of locally advanced unresectable or metastatic HER2 +ve gastric or GEJ adenocarcinoma whose tumor express PD-L1 (CPS ≥1) as determined by a validated test. 1st-line treatment in patients w/ metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC). Patients w/ hepatocellular carcinoma (HCC) who have been previously treated w/ anti-angiogenic tyrosine kinase inhibitor. In combination w/ chemotherapy w/ or w/o bevacizumab in patients w/ persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1 w/ CPS ≥1. 1st-line treatment in patients w/ advanced renal cell carcinoma (RCC) in combination w/ axitinib; lenvatinib. Monotherapy for adjuvant treatment in patients w/ RCC at increased risk of recurrence following nephrectomy & resection of metastatic lesions. In combination w/ lenvatinib in patients w/ advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting & are not candidates of curative surgery or radiation. Patients w/ high-risk early-stage triple -ve breast cancer (TNBC) in combination w/ chemotherapy as neoadjuvant treatment then continued as monotherapy as adjuvant treatment after surgery. In combination w/ chemotherapy in patients w/ locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by a validated test & who have not received prior chemotherapy for metastatic disease.

IV Adult HNSCC, cHL, urothelial carcinoma, gastric cancer, esophageal carcinoma, CRC, HCC, cervical cancer, RCC, endometrial carcinoma, TNBC, previously untreated NSCLC, or adjuvant treatment of melanoma, NSCLC or RCC 200 mg every 3 wk or 400 mg every 6 wk infusion over 30 min. Previously treated NSCLC, for unresectable or metastatic melanoma 2 mg/kg every 3 wk infusion over 30 min. RCC In combination w/ axitinib: May consider dose escalation of axitinib >5 mg initial dose at intervals of 6 wk or longer. Endometrial carcinoma & RCC In combination w/ lenvatinib: Initially lenvatinib 20 mg orally once daily until disease progression or unacceptable toxicity. Adjuvant treatment of melanoma, NSCLC or RCC Administer up to 1 yr or until disease recurrence or unacceptable toxicity. Neoadjuvant & adjuvant treatment of resectable NSCLC Treat w/ neoadjuvant Keytruda in combination w/ chemotherapy for 12 wk or until disease progression that precludes definitive surgery or unacceptable toxicity followed by adjuvant treatment as monotherapy for 39 wk or until disease recurrence or unacceptable toxicity. Neoadjuvant & adjuvant treatment of high-risk early-stage TNBC Treat w/ neoadjuvant Keytruda in combination w/ chemotherapy for 8 doses of 200 mg every 3 wk or 4 doses of 400 mg every 6 wk or until disease progression that precludes definitive surgery or unacceptable toxicity followed by adjuvant treatment as monotherapy for 9 doses of 200 mg every 3 wk or 5 doses of 400 mg every 6 wk or until disease recurrence or unacceptable toxicity.

Hypersensitivity.

Targeted Cancer Therapy

L01FF02 - pembrolizumab ; 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