Imfinzi (durvalumab)

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Imfinzi (durvalumab)

Imfinzi (durvalumab) is a medication used for the treatment of locally advanced or metastatic urothelial carcinoma (bladder cancer) and unresectable, stage III non-small cell lung cancer (NSCLC).

How to buy Imfinzi (durvalumab): You can order Imfinzi (durvalumab) from TheSocialMedwork if the drug has not been approved or is not available in your country. TheSocialMedwork processes this import on behalf of its pharmacy licensed partner NA Pharmacy Amsterdam (BIG registration No: 89912008117).

Oncology Urothelial Carcinoma, Lung Cancer
Marketing Authorisation Holder AstraZeneca Pharmaceuticals LP
Mode of Action PD-L1 blocking antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval Food and Drug Administration (FDA), USA
Strength 50 milligram / millilitre
Package 1 Vials

What is Imfinzi (durvalumab) for?

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of people with:

  • locally advanced or metastatic urothelial carcinoma (bladder cancer)

    • who have disease progression during or following platinum-containing chemotherapy

    • who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy1

  • Unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy1

How does Imfinzi (durvalumab) work?

Imfinzi (durvalumab) is a monoclonal antibody (a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody) — a type of protein that has been designed to recognise and attach to a specific structure, found in certain cells in the body. Durvalumab has been designed to attach to a receptor called PD-1, found on certain cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and, in this way, switch off the T cells. By attaching to the receptor, durvalumab prevents cancer cells from switching off T cells, thereby increasing the ability of the immune system to kill cancer cells1.

Where has Imfinzi (durvalumab) been approved?

Imfinzi (durvalumab) was approved by:

  • Food and Drug Administration (FDA), USA:

    • May 1, 2017, with an accelerated approval for locally advanced or metastatic urothelial carcinoma (bladder cancer) in patients who have disease progression during or following platinum-containing chemotherapy; or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy2

    • February 16, 2018, for unresectable, stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy3.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Imfinzi (durvalumab) taken?

The standard dosage is:

  • 10 mg/kg every 2 weeks (for both indications)

Complete information about Imfinzi (durvalumab) dosage and administration can be found in the official prescribing information listed in our resources section1.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Imfinzi (durvalumab)?

Common side effects

Urothelial carcinoma

The most common side effects listed in the prescribing information include1:

  • fatigue
  • musculoskeletal pain
  • constipation
  • decreased appetite
  • nausea
  • peripheral edema
  • urinary tract infection.

Unresectable, stage III NSCLC

The most common side effects listed in the prescribing information include1:

  • cough
  • fatigue
  • pneumonitis/radiation pneumonitis
  • upper respiratory tract infections
  • dyspnea
  • rash.

Serious side effects

The serious side effects listed in the prescribing information include1:

  • immune-mediated pulmonitis
  • immune-mediated hepatitis
  • immune-mediated colitis
  • immune-mediated endocrinopathies
  • immune-mediated nephritis
  • immune-mediated dermatologic reactions
  • infections
  • infusion related reactions.

Use in a specific population

It can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding1.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.


More Information
Working ingredient durvalumab
Shipping method Cold chain (temperature controlled)
Package 1
Therapeutic Area Oncology
Oncology Urothelial Carcinoma, Lung Cancer
Indication Unresectable, Stage III non-small cell lung cancer (NSCLC)
Indication Locally advanced or metastatic urothelial carcinoma
Administration Intravenous
Mode of Action PD-L1 blocking antibody (immunotherapy)
Strength 50
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder AstraZeneca Pharmaceuticals LP

Urothelial carcinoma

The Food and Drug Administration (FDA), USA, approval of Imfinzi (durvalumab) for locally advanced or metastatic urothelial carcinoma in previously treated patients was based on a single arm clinical trial (Study 1108). This study involved a total of 182 patients with locally advanced or metastatic urothelial carcinoma were enrolled. Patients had progressed while on or after a platinum-based therapy, including those who progressed within 12 months of receiving therapy in a neo-adjuvant or adjuvant setting1.

Results

Among the efficacy outcome measures were Overall Response Rate (ORR) and duration of response (DoR)1.

The ORR was:

  • 17% [95% CI: 11.9, 23.3] over all patients
  • 26% [95% CI: 17.8, 36.4] in patients with high PD-L1 expression
  • 4% [95% CI: 0.9, 11.5] in patients with low PD-L1 expression.

The DoR was:

  • range between 0.9+ and 19.9+ months (median not reached).

Non-Small Cell Lung Cancer (NSCLC)

The Food and Drug Administration (FDA), USA, approval of Imfinzi (durvalumab) for  Non-Small Cell Lung Cancer (NSCLC) was based on a double-blind, placebo-controlled study (PACIFIC). This study involved a total of 713 patients unresectable Stage III NSCLC who completed at least 2 cycles of concurrent platinum-based chemotherapy and definitive radiation within 42 days prior to initiation of Imfinzi (durvalumab)1. All patients received radiation, 99% received platinum-based chemotherapy1. Patients were treated for up to 12 months1.

Results

Among the efficacy outcome measures were progression-free survival (PFS) and overall survival (OS). Additional measure was the overall response rate (ORR)1.

The PFS was:

  • 16.8 [95% CI: 13, 18.1] with Imfinzi (durvalumab)
  • 5.6 [95% CI: 4.6, 7.8] with placebo.

The data for OS were data were not mature at the time of analysis1.

The ORR was:

  • 26% [95% CI: 23, 31] with Imfinzi (durvalumab)
    • complete response rate: 1% 
  • 14% [95% CI: 4.6, 7.8] with placebo
    • complete response rate: 0%.

1. Summary of Product Characteristics [FDA]: Imfinzi (durvalumab) [PDF]
    AstraZeneca, Apr. 2017.

2. FDA.gov: Approved drugs. Durvalumab (Imfinzi)
    cited on: 27/09/2017.

3. FDA Press Release: FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer     progressing
    16/02/2018.

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.