Imfinzi (durvalumab)
An approved treatment for Cholangiocarcinoma.
The same compound appears under different names depending on the context. Here is how to identify Durvalumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Durvalumab
- Brand name
- Imfinzi
- Development code
- MEDI4736
- Drug class
- Monoclonal antibody (anti-PD-L1)
- Manufacturer
- AstraZeneca
- How it's taken
- Durvalumab is given as an intravenous infusion over 60 minutes.
An immunotherapy approved, together with the chemotherapy drugs gemcitabine and cisplatin, for adults with biliary tract cancer (including cholangiocarcinoma) that is locally advanced or has spread (metastatic). It blocks PD-L1 on cancer cells, preventing them from hiding from the immune system.
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Where Durvalumab fits
Approved in combination with chemotherapy for advanced biliary tract cancers including cholangiocarcinoma. Part of the first-line immunotherapy-chemotherapy combination approach for this cancer.
How Durvalumab works
Durvalumab blocks PD-L1, a 'do not attack' signal that cancer cells use to protect themselves from the immune system. When durvalumab binds to and blocks PD-L1, it removes this protection, allowing immune cells to destroy cancer cells. This works especially well with chemotherapy, which damages cancer cells and makes them more visible to the immune system.
Mechanism: PD-L1 immune checkpoint inhibitor
Side effects and safety
In the bile duct cancer trial, the most common side effects (in 20% or more of patients) were fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and fever. As an immunotherapy, it can cause the immune system to attack healthy organs, including the lungs, colon, liver, hormone glands such as the thyroid, kidneys, skin, and pancreas. These reactions can be severe or fatal, can happen during or after treatment, and require careful monitoring. It can also cause serious infusion reactions, and it can harm an unborn baby, so women who can become pregnant should use effective birth control during treatment and for 3 months after the last dose. The label also warns about serious complications in people who have a donor (allogeneic) stem cell transplant before or after treatment. Treatment may need to be paused if serious immune-related effects occur.
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 Durvalumab
Durvalumab is given as an intravenous infusion over 60 minutes. For biliary tract cancer, durvalumab 1,500 mg is given on day 1 along with chemotherapy every 3 weeks for up to 8 cycles. After that, durvalumab continues alone every 4 weeks until disease progression.
Availability and cost
Only available as the brand-name product.
PD-L1 checkpoint inhibitor biologic used across multiple oncology indications. Specialty pricing reflects complex monoclonal antibody manufacturing and broad cancer applications.
Help paying for Imfinzi
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.
- Copay help
IMFINZI Patient Savings Program: eligible commercially insured patients may pay as little as $0 per infusion, no income requirement. Not for government insurance.
For: private insurance · source - Infusion cost help
Up to $100 per infusion toward administration costs. Not available to Massachusetts or Rhode Island residents.
For: private insurance · source - Free medicine program
IMFINZI is on the AZ&Me list. AZ&Me gives AstraZeneca medicines at no cost to eligible uninsured people or Medicare patients who cannot afford them.
For: no insurance, Medicare · source - Insurance and case manager help
Access 360 answers questions about insurance coverage, out-of-pocket costs and patient assistance programs.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Free drug is through AZ&Me (1-800-292-6363); income limits apply. AZ&Me eligibility is described at azandmeapp.com.
- 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
The Phase 3 TOPAZ-1 trial of 685 patients showed durvalumab plus chemotherapy reduced the risk of death by 20% compared to chemotherapy alone. About 25% of patients were alive at 2 years versus only 10% with chemotherapy alone.
Development history
Durvalumab was developed by AstraZeneca/MedImmune and approved by the FDA in September 2022 in combination with chemotherapy for biliary tract cancer, marking a major milestone as the first immunotherapy regimen approved for this disease.
Explore Cholangiocarcinoma trials
Other Cholangiocarcinoma treatments
Common questions about Durvalumab
▸What is Durvalumab (Imfinzi)?
An immunotherapy approved, together with the chemotherapy drugs gemcitabine and cisplatin, for adults with biliary tract cancer (including cholangiocarcinoma) that is locally advanced or has spread (metastatic). It blocks PD-L1 on cancer cells, preventing them from hiding from the immune system.
▸How does Durvalumab work?
Durvalumab blocks PD-L1, a 'do not attack' signal that cancer cells use to protect themselves from the immune system. When durvalumab binds to and blocks PD-L1, it removes this protection, allowing immune cells to destroy cancer cells. This works especially well with chemotherapy, which damages cancer cells and makes them more visible to the immune system.
▸What are the side effects of Durvalumab?
In the bile duct cancer trial, the most common side effects (in 20% or more of patients) were fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and fever. As an immunotherapy, it can cause the immune system to attack healthy organs, including the lungs, colon, liver, hormone glands such as the thyroid, kidneys, skin, and pancreas. These reactions can be severe or fatal, can happen during or after treatment, and require careful monitoring. It can also cause serious infusion reactions, and it can harm an unborn baby, so women who can become pregnant should use effective birth control during treatment and for 3 months after the last dose. The label also warns about serious complications in people who have a donor (allogeneic) stem cell transplant before or after treatment. Treatment may need to be paused if serious immune-related effects occur.
▸How is Durvalumab taken?
Durvalumab is given as an intravenous infusion over 60 minutes. For biliary tract cancer, durvalumab 1,500 mg is given on day 1 along with chemotherapy every 3 weeks for up to 8 cycles. After that, durvalumab continues alone every 4 weeks until disease progression.
▸Is Durvalumab FDA approved?
Yes, Durvalumab (Imfinzi) is FDA approved (2022) for the treatment of Cholangiocarcinoma.
▸How does durvalumab work as an immunotherapy?
Durvalumab blocks PD-L1, a protein that cancer cells use to hide from the immune system. By blocking this signal, it allows immune cells to recognize and attack cancer cells. It works especially well with chemotherapy, which damages cancer cells and makes them more visible to the immune system.
▸What did the TOPAZ-1 trial show?
The TOPAZ-1 trial of 685 patients showed durvalumab plus chemotherapy reduced the risk of death by 20% compared to chemotherapy alone. About 25% of patients were alive at 2 years versus only 10% with chemotherapy alone.
▸How is durvalumab administered for cholangiocarcinoma?
Durvalumab 1,500 mg is given as an IV infusion over 60 minutes on day 1 along with chemotherapy every 3 weeks for up to 8 cycles. After that, durvalumab continues alone every 4 weeks until disease progression.
▸What immune-related side effects can occur?
As an immunotherapy, durvalumab can cause immune-mediated effects like lung inflammation (pneumonitis), liver inflammation, colitis, and thyroid problems. These require careful monitoring and may need corticosteroid treatment or drug discontinuation.
▸Is durvalumab used for other cancers?
Yes. Durvalumab (Imfinzi) has multiple approvals across cancer types including non-small cell lung cancer, small cell lung cancer, and hepatocellular carcinoma. The cholangiocarcinoma approval came in September 2022.
▸How does durvalumab compare to pembrolizumab for biliary tract cancer?
Both are checkpoint inhibitors used with chemotherapy for biliary tract cancer. Durvalumab blocks PD-L1 while pembrolizumab blocks PD-1, targeting different sides of the same immune checkpoint pathway. Both showed survival benefits in their respective trials.