Initial US Approval:
2021
Key Clinical Studies:
RUBY (NCT03981796); GARNET (NCT02715284)
Drug Class/Description:
Programmed death receptor-1 (PD-1)-blocking antibody
Indications and Usage:
Endometrial Cancer
- in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC).
as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Mismatch Repair Deficient Recurrent or Advanced Solid Tumors
- as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.1
1This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Dosage Administration:
JEMPERLI, in combination with carboplatin and paclitaxel, for primary advanced or recurrent EC: 500 mg every 3 weeks for 6 cycles followed by 1,000 mg monotherapy every 6 weeks for all cycles thereafter.
JEMPERLI, as a single agent, for dMMR recurrent or advanced EC: 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter.
JEMPERLI, as a single agent, for dMMR recurrent or advanced solid tumors: 500 mg every 3 weeks for 4 cycles followed by 1,000 mg every 6 weeks for all cycles thereafter.
- Administer as an intravenous infusion over 30 minutes.
Dosage Forms and Strengths:
Injection: 500 mg/10 mL (50 mg/mL) solution in a single-dose vial.
Contraindications:
None.
Warnings and Precautions:
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for signs and symptoms of immune-mediated adverse reactions. Evaluate clinical chemistries, including liver enzymes, creatinine, and thyroid function, at baseline and periodically during treatment. Withhold or permanently discontinue JEMPERLI and administer corticosteroids based on the severity of reaction.
Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue JEMPERLI based on severity of reaction.
Complications of allogeneic hematopoietic stem cell transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1–blocking antibody.
Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception."
Adverse Reactions:
- Most common adverse reactions (≥20%), including laboratory abnormalities, with JEMPERLI in combination with carboplatin and paclitaxel in patients with EC are decreased hemoglobin, increased creatinine, peripheral neuropathy, decreased white blood cell count, fatigue, nausea, alopecia, decreased platelets, increased glucose, decreased lymphocytes, decreased magnesium, decreased neutrophils, increased aspartate aminotransferase (AST), arthralgia, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), decreased potassium, decreased albumin, decreased sodium, increased alkaline phosphatase, abdominal pain, dyspnea, decreased appetite, increased amylase, decreased phosphate, urinary tract infection, and vomiting.
- Most common adverse reactions (≥20%) with JEMPERLI as a single agent in patients with dMMR solid tumors are fatigue/asthenia, anemia, diarrhea, and nausea. Most common Grade 3 or 4 laboratory abnormalities (≥2%) are decreased lymphocytes, decreased sodium, increased alkaline phosphatase, and decreased albumin.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted from:
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
