Keytruda (Pembrolizumab) Issued New Dosage and Indication

April 22, 2019

The FDA has recently approved new dosage form and two new indications for the drug. 

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The FDA has approved a new dosage form and treatment of Keytruda (pembrolizumab, Merck & Co), a programmed death receptor-1-blocking antibody already indicated for various cancers.

The new dosage form is 50 mg of lyophilized powder, shipped in a single-dose vial to be reconstituted and used as an injection solution.

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Regarding new treatment approval, the FDA has expanded Keytruda’s use to be used as a first-line treatment for patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.

Keytruda has also been approved as a first-line treatment for patients with advanced renal cell carcinoma, in conjunciton with axitinib (Inlyta, Pfizer). 

Results from a randomized, multicenter, open-label trial in 861 patients indicate a statstically significant improvement in overall survival rate and progression-free survival. The most common adverse adverse recations recorded included: diarrhea, fatigue/asthenia, hypertension, hypothyroidism, decreased appetite, hepatotoxicity, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation. 

Page 2: Prescribing Information

Prescribing Information

Keytruda is indicated for patients suffering from melanoma, non-small cell lung caner, head and neck squamous cell cancer, classical Hodgkin lymphoma (cHL), primary mediastinal large b-cell lymphoma, urothelial carcinoma, micro satellite instability-high cancer (MSI-H), gastric cancer, cervical cancer, hepatocellular carcinoma, and merkel cell carcinoma (MCC).

Patients should receive 200 mg of Keytruda every three weeks, regardless of the cancer. For pediatric patients suffering from cHL, MSI-H, or MCC, the recommended dosage is 2 mg/kg up to 200 mg every three weeks. If indicated alongisde axitinib, Keytruda should be given at 200 mg every three weeks with 5 mg of axitinib orally twice daily. 

Common side effects of taking Keytruda include fatigue; pain in muscles, bones, or joints and abdomen; decreased appetite; itching; diarrhea; nausea; rash; fever; cough; shortness of breath; and constipation. When taken with the chemotherapy medications, side effects include the aforementioned as well as vomiting, hair loss, inflammation of nerves that may cause pain, and weakness and paralysis in the arms and legs.

Pediatric patients may experience a greater development of fatigue, vomiting, abdominal pain, increased level of liver enzymes and decreased levels of sodium in the blood.

Merck warns that these are not comprehensive side effects of Keytruda, and suggest patients alert physicians to the development of any particular side effects after starting the medication.

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