KEYTRUDA (Page 2 of 21)
1.15 Endometrial Carcinoma
KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1)].
KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1)].
1.16 Tumor Mutational Burden-High Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test [see Dosage and Administration (2.1)] , that have progressed following prior treatment and who have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.16)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Limitations of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
1.17 Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
1.18 Triple-Negative Breast Cancer
KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test [see Dosage and Administration (2.1)].
1.19 Adult Classical Hodgkin Lymphoma and Adult Primary Mediastinal Large B-Cell Lymphoma: Additional Dosing Regimen of 400 mg Every 6 Weeks
KEYTRUDA is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma in adults [see Indications and Usage (1.4, 1.5), Dosage and Administration (2.2)]. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety [see Clinical Pharmacology (12.2), Clinical Studies (14.19)]. Continued approval for this dosage may be contingent upon verification and description of clinical benefit in the confirmatory trials.
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Patient Selection for Single-Agent Treatment
Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:
- stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation [see Clinical Studies (14.2)].
- metastatic NSCLC [see Clinical Studies (14.2)].
- first-line treatment of metastatic or unresectable, recurrent HNSCC [see Clinical Studies (14.3)].
- previously treated recurrent locally advanced or metastatic esophageal cancer [see Clinical Studies (14.10)].
- recurrent or metastatic cervical cancer with disease progression on or after chemotherapy [see Clinical Studies (14.11)].
For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens [see Clinical Studies (14.7, 14.8)].
For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens [see Clinical Studies (14.16)].
Because the effect of prior chemotherapy on test results for tumor mutation burden (TMB-H), MSI-H, or dMMR in patients with high-grade gliomas is unclear, it is recommended to test for these markers in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
Patient Selection for Combination Therapy
For use of KEYTRUDA in combination with chemotherapy, with or without bevacizumab, select patients based on the presence of positive PD-L1 expression in persistent, recurrent, or metastatic cervical cancer [see Clinical Studies (14.11)].
For the pMMR/not MSI-H advanced endometrial carcinoma indication, select patients for treatment with KEYTRUDA in combination with lenvatinib based on MSI or MMR status in tumor specimens [see Clinical Studies (14.15)].
For use of KEYTRUDA in combination with chemotherapy, select patients based on the presence of positive PD-L1 expression in locally recurrent unresectable or metastatic TNBC [see Clinical Studies (14.18)].
Additional Patient Selection Information
Information on FDA-approved tests for patient selection is available at: http://www.fda.gov/CompanionDiagnostics .
- An FDA-approved test for the detection of not MSI-H is not currently available [see Clinical Studies (14.15)].
2.2 Recommended Dosage
| Indication | Recommended Dosage of KEYTRUDA | Duration/Timing of Treatment |
|---|---|---|
| ||
| Monotherapy | ||
| Adult patients with unresectable or metastatic melanoma | 200 mg every 3 weeks *or400 mg every 6 weeks * | Until disease progression or unacceptable toxicity |
| Adjuvant treatment of adult patients with melanoma, NSCLC, or RCC | 200 mg every 3 weeks *or400 mg every 6 weeks * | Until disease recurrence, unacceptable toxicity, or up to 12 months |
| Adult patients with NSCLC, HNSCC, cHL, PMBCL, locally advanced or metastatic Urothelial Carcinoma, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, MSI-H or dMMR Endometrial Carcinoma, Esophageal Cancer, Cervical Cancer, HCC, MCC, TMB-H Cancer, or cSCC | 200 mg every 3 weeks *or400 mg every 6 weeks * | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with high-risk BCG- unresponsive NMIBC | 200 mg every 3 weeks *or400 mg every 6 weeks * | Until persistent or recurrent high-risk NMIBC, disease progression, unacceptable toxicity, or up to 24 months |
| Pediatric patients with cHL, PMBCL, MSI-H or dMMR Cancer, MCC, or TMB- H Cancer | 2 mg/kg every 3 weeks (up to amaximum of 200 mg)* | Until disease progression, unacceptable toxicity, or up to 24 months |
| Pediatric patients (12 years and older) for adjuvant treatment of melanoma | 2 mg/kg every 3 weeks (up to amaximum of 200 mg)* | Until disease recurrence, unacceptable toxicity, or up to 12 months |
| Combination Therapy † | ||
| Adult patients with NSCLC, HNSCC, or Esophageal Cancer | 200 mg every 3 weeks *or400 mg every 6 weeks *Administer KEYTRUDA prior to chemotherapy when given on the same day. | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with Gastric Cancer | 200 mg every 3 weeks *or400 mg every 6 weeks *Administer KEYTRUDA prior to trastuzumab and chemotherapy when given on the same day. | Until disease progression, unacceptable toxicity, or up to 24 months |
| Adult patients with Cervical Cancer | 200 mg every 3 weeks *or400 mg every 6 weeks *Administer KEYTRUDA prior to chemotherapy with or without bevacizumab when given on thesame day. | Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months |
| Adult patients with RCC | 200 mg every 3 weeks *or400 mg every 6 weeks *Administer KEYTRUDA in combination with axitinib 5 mg orally twice daily ‡orAdminister KEYTRUDA in combination with lenvatinib 20 mg orally once daily. | Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months |
| Adult patients with Endometrial Carcinoma | 200 mg every 3 weeks *or400 mg every 6 weeks *Administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily. | Until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months |
| Adult patients with high-risk early-stage TNBC | 200 mg every 3 weeks *or400 mg every 6 weeks *Administer KEYTRUDA prior to chemotherapy when given on the same day. | Neoadjuvant treatment in combination with chemotherapy 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, 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.§ |
| Adult patients with locally recurrent unresectable or metastatic TNBC | 200 mg every 3 weeks *or400 mg every 6 weeks *Administer KEYTRUDA prior to chemotherapy when given on the same day. | Until disease progression, unacceptable toxicity, or up to 24 months |
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