Pembrolizumab is listed on the World Health Organization’s List of Essential Medicines and is the first time the FDA has approved a cancer drug based on tumor genetics rather than tissue type or tumor site. The approval marks the first U.S. immune system approved for this population. therapy as first-line treatment and treating patients to cure without chemotherapy
How does KEYTRUDA work?
KEYTRUDA works with your immune system to help fight cancer cells
KEYTRUDA It is an immunotherapy that helps prevent cancer cells from hiding by blocking the PD-1 pathway so that they can suppress the immune system.
KEYTRUDA thus allows the immune system to do its job: detect and fight cancer cells.
FDA-approved indications
KEYTRUDA is a prescription medicine used to treat:
1. A type of lung cancer called non-small cell lung cancer (NSCLC)
When you have early-stage non-small cell lung cancer, it can be given before surgery in combination with a chemotherapy drug containing platinum and another chemotherapy drug that can be removed by surgery, and then continued alone after surgery to help prevent the lung cancer from coming back.
It can be used with the chemotherapy drugs pemetrexed and platinum drugs as a Your preferred treatment.
It may be used as your first choice when your lung cancer has spread (advanced non-small cell lung cancer) and is a type called “squamous cell carcinoma” along with the chemotherapy drugs carboplatin and paclitaxel or the paclitaxel protein binder treatment method.
It can be used alone as your first choice of treatment when your lung cancer has not spread beyond your chest (stage III) and you cannot have surgery or chemotherapy with radiation or if your NSCLC has spread to other parts of the body (advanced NSCLC) , and your tumor tests positive for “PD-L1” and does not have abnormal “EGFR” or “ALK” genes.
It can also be used alone for advanced NSCLC if you have tried platinum-based chemotherapy but it did not work or no longer works, and your tumor tests positive for “PD-L1” and if your tumor has abnormal “EGFR” or “ALK” gene and you have also received “EGFR” or “ALK” inhibitor drugs that did not work or are no longer effective.
It can be used as a stand-alone treatment for adult lung cancer to help prevent your lung cancer from coming back after surgery to remove the tumor and you have received platinum-based chemotherapy, and you are in Stage IB and your lung cancer comes back. Tumor size 4 cm or larger, stage II or stage IIIA non-small cell lung cancer.
2. A type of skin cancer called melanoma
It can be used when your melanoma has spread or cannot be removed with surgery (advanced melanoma), or
It can be used in adults and children 12 years and older with stage IIB, IIC, or III melanoma to help prevent the melanoma and cancer-containing lymph nodes from coming back after surgery to remove them
3. A type of cancer called head and neck squamous cell carcinoma (HNSCC)
It can be used as your first choice of treatment along with the chemotherapy drugs fluorouracil and platinum when your head and neck cancer has spread or returned and cannot be removed with surgery.
It can be used alone as your first treatment when your head and neck cancer has spread or recurred and cannot be removed with surgery, and your tumor tests positive for PD-L1.
It may be used alone when your head and neck cancer has spread or has come back and you have received platinum-containing chemotherapy and the chemotherapy did not work or is no longer effective.
4. A cancer of the bladder and urinary tract called urothelial carcinoma
It can be used with the adult drug enfortumab vedotin when your bladder or urinary tract cancer has spread or cannot be removed with surgery (advanced urothelial cancer).
It is used alone when your bladder or urinary tract cancer has spread or cannot be removed with surgery (advanced urothelial cancer) and you cannot receive platinum-containing chemotherapy (a drug called cisplatin or carboplatin).
It may be used alone when you have bladder or urinary tract cancer that has spread or cannot be removed with surgery (advanced urothelial cancer) and you have received platinum-containing chemotherapy and the chemotherapy did not work or is no longer effective.
It may be used alone when your cancer has not spread to tissue near the bladder, but is at high risk of spreading (high-risk, non-muscle-invasive bladder cancer [NMIBC]) and your tumor is classified as “.” Carcinoma in situ” (CIS) and you have tried Bacillus Calmette-Guérin (BCG) treatment but it did not work and you are unable or decide not to have cystectomy
5. A cancer that laboratory tests show is a microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumor.
It can be used in adults and children to treat:
Cancer that has spread or cannot be removed with surgery (advanced cancer), and
Your condition has progressed after treatment, and you have no satisfactory treatment options.
6. A type of cancer called colon or rectal cancer
It can be used when your cancer:
has spread or cannot be removed with surgery (advanced colon or rectal cancer), and
Laboratory testing shows microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR)
7. A type of stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma
It can be used in adults in combination with fluoropyrimidine and platinum chemotherapy as your first choice of treatment when you have the following stomach cancers:
HER2 negative, and
Has spread or cannot be removed with surgery (advanced gastric cancer)
8. A type of cancer called esophageal cancer, or certain gastroesophageal junction (GEJ) cancers, cannot be cured with surgery or a combination of chemotherapy and radiation.
It can be used with platinum- and fluoropyrimidine-based chemotherapy drugs.
Can be used alone in the following situations:
You have had one or more treatments but they have not worked or are no longer working, and
Your tumor is of the “squamous” tumor type, and
Your tumor tests positive for “PD-L1”
9. There is a kind of cancer called cervical cancer
It can be used along with chemotherapy and radiation when your cervical cancer has spread to nearby tissues or organs or has affected your kidneys (classified as stage III to IVA cervical cancer according to the FIGO 2014 classification).
It can be used with chemotherapy drugs, with or without bevacizumab, if:
Your cervical cancer has not gone away (persists), has come back, or has spread (advanced cervical cancer), and
Your tumor tests positive for PD-L1.
It can be used alone when your cervical cancer:
Has come back or spread (advanced cervical cancer) and
you had chemotherapy but it didn’t work or is no longer effective, and
Your tumor tests positive for PD-L1
10. A type of kidney cancer called renal cell carcinoma (RCC)
It may be used with the drug axitinib as your first choice of treatment when your kidney cancer has spread or cannot be removed with surgery (advanced renal cell carcinoma).
It may be used alone if your risk of kidney cancer (RCC) coming back after surgery is moderate to high or high:
Removal of all or part of the kidney, or
Removal of all or part of the kidney and surgery to remove cancer that has spread to other parts of the body (metastatic disease)
11. A type of uterine cancer called advanced endometrial cancer
It can be used alone:
If lab tests show your cancer has microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR), and
you have received cancer treatment but it is no longer effective, and
Your cancer cannot be cured with surgery or radiation
12. A type of skin cancer called cutaneous squamous cell carcinoma (cSCC). It is used when your skin cancer has come back or spread and cannot be cured with surgery or radiation
13. A type of cancer called triple-negative breast cancer (TNBC)
When you have early-stage breast cancer and are at high risk of breast cancer coming back (high-risk early-stage triple-negative breast cancer), it can be used with chemotherapy drugs before surgery and then continued alone after surgery. TNBC]).
It can be used with chemotherapy drugs when your breast cancer has come back and cannot be removed with surgery or has spread (advanced TNBC) and tests positive for “PD-L1”
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