Pembrolizumab and berahyaluronidase alfa-pmph
(pem-broh-LIH-zoo-mab and ber-a-HYE-al-yoo-RON-ih-days AL-fah)
This page contains brief information about pembrolizumab and berahyaluronidase alfa-pmph and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials.
US Brand Name(s)
Keytruda QLEX
FDA Approved
Yes
FDA label information for this drug is available at DailyMed.
Use in Cancer
Pembrolizumab and berahyaluronidase alfa-pmph is approved to treat:
- Biliary tract cancer in adults that has spread or cannot be removed by surgery. It is used with gemcitabine hydrochloride and cisplatin.
- Breast cancer that is triple negative. It is used:
- with chemotherapy in adults whose cancer has the PD-L1 protein and spread or has come back and cannot be removed by surgery
- with chemotherapy before surgery and then alone after surgery in adults with early-stage cancer that has a high risk of coming back
- Cervical cancer. It is used:
- with chemotherapy and radiation therapy in adults with stage III or stage IVA cervical cancer
- with chemotherapy, with or without bevacizumab, in adults whose cancer has the PD-L1 protein and did not respond to treatment, has come back, or has spread to other parts of the body
- alone in adults whose cancer has the PD-L1 protein, has come back or spread to other parts of the body, and has gotten worse during or after chemotherapy
- Cutaneous squamous cell carcinoma (a type of skin cancer) that has spread or come back. It is used in adults whose cancer cannot be cured with surgery or radiation therapy.
- Endometrial carcinoma in adults. It is used:
- with carboplatin and paclitaxel and then alone in patients with cancer that has spread or has come back
- with lenvatinib in patients whose cancer is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), has gotten worse after other systemic therapies, and cannot be cured with surgery or radiation therapy
- alone in patients whose cancer is MSI-H or dMMR and has gotten worse after other systemic therapies, and cannot be cured with surgery or radiation therapy
- Esophageal or gastroesophageal junction cancer in adults that has spread and cannot be cured with surgery or a combination of chemotherapy and radiation therapy and has the PD-L1 protein. It is used:
- with platinum-based chemotherapy and a fluoropyrimidine
- alone in patients with squamous cell cancer that has been treated with at least one systemic therapy
- Gastric (stomach) cancer or gastroesophageal junction cancer adenocarcinoma that has spread or cannot be treated with surgery. It is used in adults as the first treatment with:
- trastuzumab, a fluoropyrimidine, and platinum-based chemotherapy in patients whose cancer has the PD-L1 protein and is HER2 positive
- a fluoropyrimidine and platinum-based chemotherapy in patients whose cancer has the PD-L1 protein and is HER2 negative
- Hepatocellular carcinoma (a type of liver cancer) in adults who have had hepatitis B and have been treated with systemic therapy that did not contain a PD-1- or PD-L1-targeted therapy.
- Melanoma. It is used in:
- adults whose cancer cannot be removed by surgery or has spread to other parts of the body
- adults and children aged 12 years and older with stage IIB, stage IIC, or stage III melanoma to prevent the cancer from coming back after it has been removed by surgery
- Malignant pleural mesothelioma. It is given with pemetrexed and platinum chemotherapy as the first treatment in adults whose cancer has spread or cannot be removed by surgery.
- Merkel cell carcinoma in adults and children 12 years of age or older whose cancer has come back or spread.
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer that has spread to other parts of the body or cannot be removed by surgery. MSI-H and dMMR cancers have certain genetic mutations and may not respond to some types of treatment. It is used to treat:
- solid tumors in adults and children aged 12 years and older whose cancer got worse after other treatment and cannot be treated with other therapies
- colorectal cancer in adults
- Non-small cell lung cancer. It is used in adults:
- with pemetrexed and platinum-based chemotherapy as the first treatment in patients with nonsquamous cancer that has spread to other parts of the body and does not have a mutation in the EGFR gene or ALK gene
- with carboplatin and either paclitaxel or paclitaxel albumin-stabilized nanoparticle formulation as the first treatment in patients with squamous cancer that has spread to other parts of the body
- with platinum-based chemotherapy before surgery and then alone after surgery to help keep the cancer from coming back
- alone as the first treatment in adults with cancer that has the PD-L1 protein, does not have a mutation in the EGFR gene or ALK gene, and either has spread to other parts of the body or is stage III and cannot be treated with surgery or chemoradiation
- alone in patients whose cancer has spread to other parts of the body, has the PD-L1 protein, and has gotten worse during or after treatment with platinum-based chemotherapy; if the cancer has EGFR or ALK gene mutations, patients must have received EGFR inhibitor or ALK inhibitor therapy and it did not work or is no longer working
- alone in patients with stage IB, stage IIA, stage IIB, or stage IIIA cancer after platinum-based chemotherapy and surgery to help keep the cancer from coming back
- Ovarian epithelial, fallopian tube, or primary peritoneal cancer. It is used with paclitaxel, with or without bevacizumab, in adults who have received one or two previous treatments and whose cancer has the PD-L1 protein and did not respond to platinum chemotherapy.
- Renal cell carcinoma (a type of kidney cancer). It is used:
- with axitinib or lenvatinib as the first treatment in adults whose cancer has spread
- after surgery to remove the kidney and metastatic cancer (if any) in adults whose cancer has a high risk of coming back
- Solid tumors that are tumor mutational burden-high (TMB-H) and have spread to other parts of the body or cannot be removed by surgery. It is used in adults and children aged 12 years and older whose cancer got worse after treatment and who are not able to receive other therapies.¹
- Squamous cell carcinoma of the head and neck. It is used:
- with platinum-based chemotherapy and fluorouracil as the first treatment in adults whose cancer has come back or has spread and cannot be removed by surgery
- alone as the first treatment in patients whose cancer has come back or has spread and cannot be removed by surgery and whose tumors have the PD-L1 protein
- alone in patients whose cancer has come back or has spread and got worse during or after treatment with platinum-based chemotherapy
- alone before surgery in adults whose cancer has the PD-L1 protein and has spread; then after surgery it is used with radiation therapy with or without cisplatin and then alone to help keep the cancer from coming back
- Urothelial carcinoma (a type of bladder cancer). It is used:
- with enfortumab vedotin in adults whose cancer has spread
- with enfortumab vedotin before surgery and after surgery in adults whose cancer has spread to the bladder muscle and who cannot receive cisplatin-containing chemotherapy
- alone in adults whose cancer has spread and cannot be treated with platinum-based chemotherapy or has gotten worse during or after treatment with platinum-based chemotherapy
- alone when surgery is not an option in adults with carcinoma in situ, a type of bladder cancer that has not spread to the bladder muscle but is at high risk of spreading and that did not respond to treatment with bacillus Calmette-Guérin (BCG)
¹This use is approved under FDA's Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that pembrolizumab and berahyaluronidase alfa-pmph provides a clinical benefit in these patients.
Pembrolizumab and berahyaluronidase alfa-pmph is also being studied in the treatment of other types of cancer.
More About Pembrolizumab and Berahyaluronidase alfa-pmph
Definition from the NCI Thesaurus - Detailed scientific definition and other names for this drug.
MedlinePlus Information on Pembrolizumab and berahyaluronidase alfa-pmph - A lay language summary of important information about this drug.
Research Results and Related Resources
Targeted Therapy to Treat Cancer
Clinical Trials Accepting Patients
Find Clinical Trials for Pembrolizumab and berahyaluronidase alfa-pmph - Check for trials from ClinicalTrials.gov.