PPIDT00394
Drug Information
| Name | Cemiplimab |
|---|---|
| Sequence | EVQLLESGGVLVQPGGSLRLSCAASGFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYFADSVKGRFTISRDNSKNTLYLQMNSLKGEDTAVYYCVKWGNIYFDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK |
| DrugBank_ID | DB14707 |
| Type | biotech |
| Indication | Cemiplimab is indicated to treat: - **Locally advanced or metastatic cutaneous squamous cell carcinoma (mCSCC)** in patients who are not candidates for curative surgery or curative radiation.[L39804, L43872] - **Locally advanced basal cell carcinoma (laBCC)** in previously treated patients with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.[L39804, L43872] - **Metastatic basal cell carcinoma (mBCC)** in patients who were previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for mBCC may be contingent upon verification and description of clinical benefit.[L39804, L43872] - **Locally advanced non-small cell lung cancer (NSCLC)** in combination with platinum‐based chemotherapy for the first‐line treatment of adults with no EGFR, ALK or ROS1 aberrations, who are not candidates for surgical resection or definitive chemoradiation. It is also indicated to treat **metastatic NSCLC** in combination with platinum‐based chemotherapy as first-line treatment in adults.[L43902] - Locally advanced or metastatic NSCLC as monotherapy for the first-line treatment of adults whose tumours have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations. Patients with locally advanced NSCLC must not be candidates for surgical resection or definitive chemoradiation.[L43902] - **Recurrent or metastatic cervical cancer** in adults with disease progression on or after platinum-based chemotherapy.[L43872] |
Dosage Forms
| Form | Route | Strength |
|---|---|---|
| Injection | Intravenous |
50 mg/1mL
|
| Injection, solution, concentrate | Intravenous |
350 mg
|
| Injection, solution, concentrate | Intravenous; Parenteral |
350 MG
|
| Solution | Intravenous |
250 mg / 5 mL
|
| Solution | Intravenous |
350 mg / 7 mL
|
| Solution | Intravenous |
350.0 mg
|