Imfinzi

Lung Cancer

Imfinzi is approved for several specific types and stages of lung cancer:

• Non-small cell lung cancer (NSCLC): It is used for stage III NSCLC that cannot be removed by surgery and has not worsened after treatment with chemotherapy and radiation.
• Small cell lung cancer (SCLC): It is used in combination with chemotherapy for extensive-stage SCLC. It is also used for limited-stage SCLC that has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Biliary Tract and Liver Cancers

• Biliary tract cancer: Imfinzi is used in combination with chemotherapy to treat adults with locally advanced or metastatic biliary tract cancer, which includes bile duct cancer and gallbladder cancer.
• Hepatocellular carcinoma: It is used in combination with tremelimumab to treat adults with this type of liver cancer when it cannot be removed by surgery.

Digestive and Reproductive System Cancers

• Gastric and gastroesophageal junction (GEJ) cancers: It is used with chemotherapy for adults with resectable gastric or GEJ adenocarcinoma. It is given before surgery and then continued alone after surgery.
• Endometrial cancer: It is used in combination with chemotherapy for adults with certain types of advanced or recurrent endometrial cancer that are mismatch repair deficient (dMMR).

Bladder Cancer

Imfinzi is used for adults with muscle-invasive bladder cancer. In these cases, it is typically administered before surgery (neoadjuvant treatment) and continued after surgery (adjuvant treatment).

Immune System Activation

Imfinzi belongs to a class of drugs known as monoclonal antibodies, specifically immune checkpoint inhibitors. Its primary function is to block a specific protein called programmed death-ligand 1 (PD-L1).

The Role of PD-L1

In a healthy body, the immune system uses "checkpoints" to prevent it from attacking normal cells. Some cancer cells produce high amounts of the PD-L1 protein to exploit these checkpoints. When PD-L1 binds to certain receptors on T-cells (a type of white blood cell), it sends a signal that tells the immune system to leave the cancer cell alone. This allows the tumor to grow and spread undetected.

How Imfinzi Works

Imfinzi works by attaching itself to the PD-L1 protein on the surface of cancer cells and some immune cells. By doing this, it prevents PD-L1 from interacting with the receptors on T-cells. This action effectively:

• Removes the "mask" that cancer cells use to hide from the immune system.
• Reactivates T-cells, allowing them to identify the cancer cells as a threat.
• Triggers an immune response where the body's own defenses begin to attack and destroy the tumor cells.

Because Imfinzi works by stimulating the immune system, it may also cause the immune system to attack normal, healthy tissues in any part of the body.

Common Side Effects

The most frequently reported side effects of Imfinzi include:

• Feeling tired or weak (fatigue)
• Muscle, joint, or bone pain
• Cough or shortness of breath
• Decreased appetite
• Nausea or constipation
• Diarrhea
• Skin rash or itchy skin
• Swelling in the hands or feet
• Upper respiratory tract infections

Serious Side Effects

Imfinzi works by affecting the immune system, which can sometimes cause the immune system to attack healthy tissues and organs. These immune-mediated reactions can be severe or life-threatening and may occur during or after treatment.

Immune-Mediated Reactions

• Lung problems: New or worsening cough, chest pain, or shortness of breath (pneumonitis).
• Liver problems: Yellowing of the skin or eyes (jaundice), severe nausea, dark urine, or pain on the right side of the stomach area.
• Intestinal problems: Severe diarrhea, blood in stools, or severe stomach pain (colitis).
• Hormone gland problems: Changes in mood or behavior, headaches, extreme tiredness, weight changes, or increased thirst and urination (affecting the thyroid, pituitary, or adrenal glands, or causing diabetes).
• Kidney problems: Changes in the amount or color of urine, or swelling in the ankles.
• Skin reactions: Severe rash, blistering, or peeling.

Other Serious Risks

Other serious complications may include:

• Infusion reactions: Fever, chills, flushing, or dizziness occurring during the injection.
• Severe infections: Increased risk of developing serious infections.
• Organ transplant rejection: Imfinzi may increase the risk of rejection in people who have had an organ or stem cell transplant.

Immune-Mediated Adverse Reactions

Imfinzi is an immunotherapy that works by helping the immune system attack cancer cells. However, it may also cause the immune system to attack healthy parts of the body. These reactions can occur in any organ or tissue and may become severe or life-threatening. Common areas affected include:

• Lungs: Inflammation (pneumonitis) can cause shortness of breath, chest pain, or a new cough.
• Intestines: Colitis can lead to diarrhea, blood in the stool, or severe stomach pain.
• Liver: Hepatitis may cause yellowing of the skin or eyes (jaundice), dark urine, or severe nausea.
• Hormone Glands: Issues with the thyroid, pituitary, or adrenal glands, as well as type 1 diabetes, can occur.
• Kidneys: Nephritis can lead to changes in the amount or color of urine.
• Skin: Severe rashes, blistering, or peeling may occur.

Infusion Reactions

Some patients experience reactions during or shortly after the intravenous infusion. Symptoms may include chills, shaking, itching, flushing, or difficulty breathing.

Pregnancy and Breastfeeding

Imfinzi can cause harm to an unborn baby. Effective birth control is typically recommended during treatment and for several months after the final dose. Breastfeeding is generally discouraged during treatment and for a period following the last dose.

Stem Cell Transplant Risks

There is an increased risk of serious complications in patients who receive an allogeneic hematopoietic stem cell transplant (HSCT) after treatment with Imfinzi.

Pregnancy

Imfinzi can cause harm to an unborn baby. Healthcare providers typically perform a pregnancy test before starting treatment to ensure the patient is not pregnant. It is important to discuss pregnancy status or plans for pregnancy with a healthcare provider.

Contraception

Individuals who can become pregnant are advised to use effective birth control during treatment and for at least 3 months after the final dose of Imfinzi.

Breastfeeding

It is unknown if Imfinzi passes into breast milk. Due to the potential for serious side effects in a nursing child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

Dosage Forms

Imfinzi is supplied as a sterile, preservative-free solution for intravenous use. It is available in the following form:

• Intravenous Injection: A clear to opalescent, colorless to slightly yellow solution provided in single-dose vials.

This medication is administered as an infusion into a vein by a healthcare provider in a clinical setting.

FDA Approval Status

Imfinzi was first approved by the U.S. Food and Drug Administration (FDA) in 2017. It is a programmed death-ligand 1 (PD-L1) blocking antibody that helps the immune system attack cancer cells.

Approved Indications

The FDA has granted approval for Imfinzi to treat several specific conditions:

• Lung Cancer: It is approved for adults with unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. It is also used for both limited-stage and extensive-stage small cell lung cancer (SCLC).
• Biliary Tract Cancer: Imfinzi is approved for use in combination with chemotherapy for adults with locally advanced or metastatic biliary tract cancer.
• Liver Cancer: It is approved in combination with tremelimumab for the treatment of adults with unresectable hepatocellular carcinoma.
• Bladder Cancer: It is approved for use with chemotherapy as a treatment before and after surgery for adults with muscle-invasive bladder cancer (MIBC).
• Gastric and Gastroesophageal Junction Cancer: It is approved for use with chemotherapy for adults with resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Regulatory Requirements

There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) associated with Imfinzi. The FDA continues to monitor the drug for immune-mediated adverse reactions, which occur when the immune system attacks healthy tissues or organs during treatment.

Factors Influencing Cost

Several factors determine the total cost of treatment with Imfinzi, including:

• Insurance Coverage: Your specific health insurance plan, including deductibles, copayments, and coinsurance, will play a major role in your out-of-pocket expenses.
• Treatment Setting: Because Imfinzi is administered as an intravenous (IV) infusion by a healthcare professional, you may incur costs for the office visit and the administration procedure in addition to the drug itself.
• Dosage and Frequency: The amount of medication you receive and how often you receive it depends on the type of cancer being treated and your body weight.

Generic and Biosimilar Availability

Imfinzi is a brand-name biologic medication. Currently, there are no biosimilar or generic versions of durvalumab available, which typically means the cost remains higher than for drugs with generic alternatives.

Financial Assistance Programs

The manufacturer may offer patient assistance programs or co-pay cards to help eligible individuals manage the cost of the medication. Patients are encouraged to speak with their healthcare provider or insurance company to explore available financial support options.