Keytruda (pembrolizumab)
An approved treatment for Cholangiocarcinoma.
The same compound appears under different names depending on the context. Here is how to identify Pembrolizumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Pembrolizumab
- Brand name
- Keytruda
- Development code
- MK-3475
- Drug class
- Monoclonal antibody (anti-PD-1)
- Manufacturer
- Merck
- How it's taken
- Pembrolizumab is given as an intravenous infusion over 30 minutes, either 200 mg every 3 weeks or 400 mg every 6 weeks, with gemcitabine and cisplatin chemotherapy for biliary tract cancer.
A widely used immunotherapy approved, together with gemcitabine and cisplatin chemotherapy, as a first-line treatment option for biliary tract cancer (including cholangiocarcinoma) that is locally advanced and cannot be removed by surgery, or that has spread (metastatic).
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Where Pembrolizumab fits
Used in cholangiocarcinoma as part of combination regimens with chemotherapy. More broadly, it's one of the most widely used immunotherapy agents across solid tumors.
How Pembrolizumab works
Pembrolizumab removes the brakes from immune cells by blocking the PD-1 protein. Cancer cells often hide by turning on this 'off switch,' but pembrolizumab blocks it, allowing immune cells to recognize and attack cancer. Combined with chemotherapy, the chemotherapy first damages cancer cells, making them easier targets.
Mechanism: PD-1 immune checkpoint inhibitor
Side effects and safety
Common side effects include fatigue, nausea, diarrhea, rash, fever, cough, and decreased appetite. More serious immune-related effects, which can be severe or fatal, can affect any organ, including the lungs, colon, liver, hormone glands (such as the thyroid), kidneys and skin, and can cause rejection of a transplanted organ. The label also warns about infusion reactions, serious or fatal complications in people who have a donor (allogeneic) stem cell transplant before or after treatment, an increased risk of death when combined with a thalidomide-type drug and dexamethasone for multiple myeloma (not recommended outside clinical trials), and harm to an unborn baby, so people who can become pregnant should use effective birth control during treatment and for 4 months after the last dose. These require immediate medical attention and may require stopping the drug.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Pembrolizumab
Pembrolizumab is given as an intravenous infusion over 30 minutes, either 200 mg every 3 weeks or 400 mg every 6 weeks, with gemcitabine and cisplatin chemotherapy for biliary tract cancer. Treatment continues until the cancer grows, side effects become too severe, or for up to 24 months. A version given as a shot under the skin, Keytruda Qlex, is also approved for this use. Treatment is given at a medical facility.
Availability and cost
Only available as the brand-name product.
Blockbuster PD-1 checkpoint inhibitor used across dozens of cancer types. While not orphan-priced per se, its specialty biologic manufacturing and broad oncology role drive pricing.
Help paying for Keytruda
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Insurance and case manager help
The Merck Access Program helps with insurance coverage questions, co-pay assistance options for eligible patients, and eligibility for free medicine.
The official page does not say who qualifies. Ask the program. · source - Free medicine program
Merck Patient Assistance Program gives Keytruda free for up to 1 year to eligible US residents without coverage who meet income limits; hardship exceptions possible.
For: no insurance · source
Good to know: Keytruda.com mentions co-pay assistance options for eligible patients but gives no specific co-pay offer terms, so none is listed. Free drug is through the separate Merck Patient Assistance Program, Inc.; income limits apply.
- From a charity · The Assistance FundBiliary Tract Cancer fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
In the KEYNOTE-966 Phase 3 trial of 1,069 patients with biliary tract cancer, pembrolizumab plus chemotherapy reduced the risk of death by 17% compared to chemotherapy alone. FDA approved it for biliary tract cancer in 2023.
Development history
Pembrolizumab was developed by Merck as a humanized anti-PD-1 antibody. It has become one of the most widely used cancer immunotherapies, with approvals across more than 20 different cancer types.
Explore Cholangiocarcinoma trials
Other Cholangiocarcinoma treatments
Common questions about Pembrolizumab
▸What is Pembrolizumab (Keytruda)?
A widely used immunotherapy approved, together with gemcitabine and cisplatin chemotherapy, as a first-line treatment option for biliary tract cancer (including cholangiocarcinoma) that is locally advanced and cannot be removed by surgery, or that has spread (metastatic).
▸How does Pembrolizumab work?
Pembrolizumab removes the brakes from immune cells by blocking the PD-1 protein. Cancer cells often hide by turning on this 'off switch,' but pembrolizumab blocks it, allowing immune cells to recognize and attack cancer. Combined with chemotherapy, the chemotherapy first damages cancer cells, making them easier targets.
▸What are the side effects of Pembrolizumab?
Common side effects include fatigue, nausea, diarrhea, rash, fever, cough, and decreased appetite. More serious immune-related effects, which can be severe or fatal, can affect any organ, including the lungs, colon, liver, hormone glands (such as the thyroid), kidneys and skin, and can cause rejection of a transplanted organ. The label also warns about infusion reactions, serious or fatal complications in people who have a donor (allogeneic) stem cell transplant before or after treatment, an increased risk of death when combined with a thalidomide-type drug and dexamethasone for multiple myeloma (not recommended outside clinical trials), and harm to an unborn baby, so people who can become pregnant should use effective birth control during treatment and for 4 months after the last dose. These require immediate medical attention and may require stopping the drug.
▸How is Pembrolizumab taken?
Pembrolizumab is given as an intravenous infusion over 30 minutes, either 200 mg every 3 weeks or 400 mg every 6 weeks, with gemcitabine and cisplatin chemotherapy for biliary tract cancer. Treatment continues until the cancer grows, side effects become too severe, or for up to 24 months. A version given as a shot under the skin, Keytruda Qlex, is also approved for this use. Treatment is given at a medical facility.
▸Is Pembrolizumab FDA approved?
Yes, Pembrolizumab (Keytruda) is FDA approved (2023) for the treatment of Cholangiocarcinoma.
▸How widely is pembrolizumab used in oncology?
Pembrolizumab (Keytruda) is one of the most widely used cancer immunotherapies worldwide, with approvals across more than 20 different cancer types. The cholangiocarcinoma/biliary tract cancer indication is one of its many applications.
▸What did the KEYNOTE-966 trial show for biliary cancer?
The KEYNOTE-966 trial of 1,069 patients with biliary tract cancer showed pembrolizumab plus chemotherapy reduced the risk of death by 17% compared to chemotherapy alone, leading to FDA approval in 2023.
▸How does pembrolizumab differ from durvalumab?
Pembrolizumab blocks PD-1 (on immune cells) while durvalumab blocks PD-L1 (on cancer cells). Both disrupt the same immune checkpoint pathway but from different sides. Both are approved with chemotherapy for biliary tract cancer.
▸What immune-related side effects can occur?
Pembrolizumab can cause immune-related inflammation of the lungs, colon, liver, thyroid, and other organs. More serious cases require immediate medical attention and may involve corticosteroid treatment or stopping the drug.
▸How is pembrolizumab administered?
Pembrolizumab is given as an IV infusion over 30 minutes, either every 3 weeks or every 6 weeks, with gemcitabine and cisplatin for biliary tract cancer. Treatment continues until the cancer grows, side effects become too severe, or for up to 24 months. A shot under the skin, Keytruda Qlex, is also approved for this use.
▸Does pembrolizumab require biomarker testing?
For biliary tract cancer, pembrolizumab is approved broadly without requiring specific biomarker testing. However, MSI-H/dMMR or TMB-high status may predict enhanced response to pembrolizumab across tumor types.