Formulation and specifications: Injection: 100mg (4ml)/bottle
Indications:
1. Pabrolizumab in combination with pemetrexed and platinum-based chemotherapeutic agents is indicated for the first-line treatment of EGFR mutation-negative and ALK-negative metastatic non-squamous NSCLC.
2. Pabrolizumab is indicated for first-line monotherapy in locally advanced or metastatic NSCLC with EGFR mutation-negative and ALK-negative disease as assessed by a PD-L1 tumor percentage score (TPS) ≥ 1% as approved by the State Drug Administration.
3. Pabrolizumab in combination with carboplatin and paclitaxel is indicated for first-line treatment of patients with metastatic squamous NSCLC.
Key points for rational drug use:
1. Treatment with pabrolizumab should be continued until disease progression or intolerable toxicity occurs, with the possibility of observing atypical responses, as long as clinical benefit is observed. If the patient is clinically stable, continued treatment with this product may be considered until disease progression is confirmed, even if there is preliminary evidence of disease progression, based on the judgment of overall clinical benefit.
2. The first first-line lung cancer indication for pablizumab approved by the State Drug Administration was based on the results of the global phase III clinical study KEYNOTE-189, and the approved lung cancer indication dose in China is 200 mg every 3 weeks or 400 mg every 6 weeks administered by intravenous infusion.
3. Systemic glucocorticoids or other immunosuppressive agents should be avoided prior to the use of this product because they may affect the pharmacodynamic activity and efficacy of this product. However, systemic glucocorticoids or other immunosuppressive agents may be used to treat immune-mediated adverse reactions after administration of this product has been initiated.
4. Depending on the safety and tolerability of individual patients, dosing may need to be suspended or discontinued and no dose increases or decreases are recommended.
5. The occurrence of grade 4 or recurrent grade 3 adverse reactions and the persistence of grade 2 or 3 adverse reactions despite therapeutic modifications should result in permanent discontinuation of pabrolizumab.
6. No dose adjustment is required in elderly patients (≥65 years).
7. No dose adjustment is required in patients with mild to moderate renal impairment; limited data are available for patients with severe renal impairment.
8. No dose adjustment is required in patients with mild hepatic impairment, and no studies have been performed in patients with moderate to severe hepatic impairment.
9. Pabrolizumab may cause immune-related adverse reactions. Because adverse reactions may occur during pabrolizumab therapy or at any time after pabrolizumab therapy is discontinued, patient monitoring should be continued (at least until 5 months after the last dose).
10. For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm the etiology or to exclude other etiologies. Depending on the severity of the adverse reaction, pabrolizumab should be temporarily discontinued and glucocorticoid therapy applied. When immune-related adverse reactions improve to ≤ grade 1, a gradual reduction of glucocorticoids over a period of at least one month until discontinuation is required. Based on limited clinical study data, other systemic immunosuppressive agents may be considered in the event of immune-related adverse reactions that are not controlled by glucocorticoids. If adverse reactions remain at ≤ grade 1 and the glucocorticoid dose has been reduced to ≤ 10 mg prednisone per day or equivalent, pabrolizumab therapy may be restarted within 12 weeks of the last pabrolizumab dose.
11. Treatment with pabrolizumab should not be restarted while the patient is receiving immunosuppressive doses of glucocorticoids or other immunosuppressive agents.
12. Pabrolizumab therapy must be permanently discontinued in the event of any severe, recurrent immune-related adverse reactions and any life-threatening immune-related adverse reactions.
13. Pabrolizumab is a human monoclonal antibody, and because monoclonal antibodies are not metabolized by CYP450 or other drug-metabolizing enzymes, inhibition or induction of these enzymes by the drugs used in combination is not expected to affect the pharmacokinetic properties of pabrolizumab.
*14. The US FDA, EU EMA, and Japanese PMDA approvals for pabrolizumab also include second-line monotherapy for advanced NSCLC with PD-L1 expression ≥1% based on exclusion of EGFR or ALK positivity. The FDA also approved pabolizumab monotherapy for the treatment of unresectable or metastatic MSI-H or mismatch repair-deficient solid tumors in adults and children and unresectable or metastatic solid tumors with high tumor mutational load (TMB-H), including small cell lung cancer. These indications are not currently approved in China and may be used properly with adequate patient communication and in accordance with FDA-approved usage.