For NSCLC, HNSCC, cHL (adult and pediatric), PMBCL (adult and pediatric), locally advanced or metastatic urothelial carcinoma, MSI-H/dMMR cancer (adult and pediatric), MSI-H/dMMR CRC, MSI-H/dMMR endometrial carcinoma, gastric cancer, esophageal cancer, cervical cancer, HCC, MCC (adult and pediatric), TMB-H cancer (adult and pediatric), cSCC, or locally recurrent unresectable or metastatic TNBC:
Treatment with KEYTRUDA should continue until disease progression, unacceptable toxicity, or up to 24 months.
For unresectable or metastatic melanoma:
Treatment should continue until disease progression or unacceptable toxicity.
For adult and pediatric patients (12 years and older) for adjuvant treatment: Completely resected stage IIB, IIC, or III melanoma
Treatment should continue until disease recurrence, unacceptable toxicity, or for up to 12 months.
For adjuvant treatment of adult patients with RCC:
Treatment should continue until disease recurrence, unacceptable toxicity, or for up to 12 months.
For advanced RCC:
Treatment with KEYTRUDA + axitinib (5 mg orally bid) should continue until disease progression, unacceptable toxicity or, for KEYTRUDA, up to 24 months. When axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5-mg dose may be considered at intervals of 6 weeks or longer. Refer to the Prescribing Information for axitinib for recommended dosing information, as appropriate.
For high-risk BCG-unresponsive NMIBC:
Treatment should continue until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months.
For NSCLC, HNSCC, gastric cancer, locally recurrent unresectable or metastatic TNBC, or esophageal cancer:
When administering KEYTRUDA in combination with chemotherapy, administer KEYTRUDA prior to chemotherapy when given on the same day. Refer to the Prescribing Information for the chemotherapy agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
For cervical cancer:
When administering KEYTRUDA in combination with chemotherapy with or without bevacizumab, administer KEYTRUDA prior to chemotherapy with or without bevacizumab when given on the same day. Refer to the Prescribing Information for the chemotherapy agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
For high-risk early-stage TNBC
When administering KEYTRUDA in combination with chemotherapy as neoadjuvant treatment for adult patients with high-risk early-stage TNBC, treatment should continue for 24 weeks (8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks), or until disease progression or unacceptable toxicity. This should be followed by adjuvant treatment with KEYTRUDA as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks), or until disease recurrence or unacceptable toxicity.
Patients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single-agent KEYTRUDA.
The 400-mg Q6W dosing regimen is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials.
When administering KEYTRUDA in combination with chemotherapy, administer KEYTRUDA prior to chemotherapy when given on the same day. Refer to the Prescribing Information for the chemotherapy agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.