IMFINZI in combination with chemotherapy* is the first FDA approval for adults with locally advanced or metastatic bile duct cancer or gallbladder cancer to take as a first treatment.
A clinical trial compared 2 groups of adults with locally advanced or metastatic bile duct cancer (cholangiocarcinoma) or gallbladder cancer:
received IMFINZI + chemotherapy*
received placebo (no medicine)
+ chemotherapy*
months taking
IMFINZI + chemotherapy*
months taking
placebo with chemotherapy*
IMFINZI with chemotherapy* lowered the risk of death by 20% compared to chemotherapy* alone.
†The study measured median overall survival, which is the length of time from the start of treatment to the time that half of the patients were still living.
Data cutoff was August 11, 2021.
‡Based on the limits of the analysis, results are descriptive only and your experience may differ.
Data cutoff was October 23, 2023.
In the original clinical trial analysis, IMFINZI with chemotherapy* lowered the risk of cancer growing or spreading by 25% compared to chemotherapy* alone.
Within the trial, half of the people taking IMFINZI with chemotherapy* lived without their tumors growing or spreading for 7 months, compared to 6 months for people taking chemotherapy* alone.
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*Gemcitabine and cisplatin.
IMFINZI is a medicine that may treat certain cancers by working with your immune system. IMFINZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
IMFINZI is a prescription medicine used to treat adults with a type of cancer called biliary tract cancer (BTC), including cancer of the bile ducts (cholangiocarcinoma) and gallbladder cancer. IMFINZI may be used in combination with chemotherapy medicines gemcitabine and cisplatin when your BTC has spread to nearby tissues (locally advanced), or has spread to other parts of the body (metastatic).
It is not known if IMFINZI is safe and effective in children.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with IMFINZI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with IMFINZI if you have severe side effects
Before you receive IMFINZI, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of IMFINZI when used with other anticancer medicines in people with BTC include feeling tired, nausea, constipation, decreased appetite, stomach (abdominal) pain, rash, and fever.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IMFINZI. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca products. If you prefer to
report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca products. If you prefer to
report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
IMFINZI is a prescription medicine used to treat adults with a type of cancer called biliary tract cancer (BTC), including cancer of the bile ducts (cholangiocarcinoma) and gallbladder cancer. IMFINZI may be used in combination with chemotherapy medicines gemcitabine and cisplatin when your BTC has spread to nearby tissues (locally advanced), or has spread to other parts of the body (metastatic).
It is not known if IMFINZI is safe and effective in children.
Please see Full Prescribing Information including Medication Guide for IMFINZI.
IMFINZI is a medicine that may treat certain cancers by working with your immune system. IMFINZI can cause your immune...
IMFINZI is a medicine that may treat...
IMFINZI is a prescription medicine used to treat adults with a type of cancer called biliary tract cancer (BTC), including cancer of the bile ducts (cholangiocarcinoma) and gallbladder cancer. IMFINZI may be used...
IMFINZI is a medicine that may treat certain cancers by work...
IMFINZI is a medicine that may treat certain cancers by working with your immune system. IMFINZI can cause your immune system to...