Overview

Imfinzi is a medicine used to treat lung cancer. It is for use in adults with:

  • non-small cell lung cancer (NSCLC) that is locally advanced (meaning it has spread into tissues around the lungs, but not to other parts of the body) and cannot be removed by surgery and is not getting worse after radiation treatment and platinum-based chemotherapy (medicines to treat cancer). Imfinzi is used on its own and only when the cancer produces a protein known as PD-L1;
  • NSCLC that has metastasised (spread) outside the lungs. Imfinzi is given together with tremelimumab (another cancer medicine) and platinum-based chemotherapy, and is used when the cancer has no mutations (changes) in the so-called EGFR and ALK genes;
  • small cell lung cancer (SCLC) that has spread within the lungs or to other parts of the body (extensive-stage SCLC) and has not been treated previously. Imfinzi is given together with etoposide and either carboplatin or cisplatin (chemotherapy medicines);
  • biliary tract cancer (BTC), a cancer of the bile ducts (tubes that carry bile from the liver and gallbladder to the gut). It is used in combination with gemcitabine and cisplatin (other cancer medicines) in patients who have not been treated previously, when the cancer cannot be removed by surgery or has metastasised;
  • hepatocellular carcinoma (HCC, a type of liver cancer) in patients who have not been treated before and whose disease is advanced or cannot be removed by surgery. It is used in combination with tremelimumab.

Imfinzi contains the active substance durvalumab.

Imfinzi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer. It is given by infusion (drip) into a vein.

The dose of Imfinzi and how often it is given depends on the type of cancer being treated. Treatment can continue for as long as the patient benefits from it or for up to 1 year for locally advanced NSCLC.

Treatment may be paused or stopped permanently if the patient gets severe side effects.

For more information about using Imfinzi, see the package leaflet or contact your doctor or pharmacist.

The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to attach to a protein called PD-L1, which is present on the surface of many cancer cells.

PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. By attaching to PD-L1 and blocking its effects, Imfinzi increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.

Non-small cell lung cancer

In one main study of 713 patients with locally advanced non-small cell lung cancer, patients given Imfinzi lived on average for around 17 months without their disease getting worse, compared with 6 months for those given placebo (a dummy treatment). Preliminary results also indicated that patients given Imfinzi lived longer overall compared with patients on placebo.

In another main study of patients with metastatic NSCLC, 338 patients given Imfinzi in combination with tremelimumab and chemotherapy lived on average for 14 months, compared with 12 months for 337 patients given only chemotherapy. They also lived longer without their disease getting worse: around 6 months on average, compared with 5 months for patients who only received chemotherapy.

Small cell lung cancer

In another main study of 805 patients with extensive-stage small cell lung cancer, patients given Imfinzi together with chemotherapy lived on average for 13 months compared with 10 months for those given chemotherapy alone.

Biliary tract cancer

In a study with 685 patients with advanced biliary tract cancer, patients who received Imfinzi plus gemcitabine and cisplatin lived on average for 12.8 months, compared with 11.5 for those who received placebo plus gemcitabine and cisplatin.

Hepatocellular carcinoma

In a main study in patients with advanced hepatocellular cancer who had not been treated before, Imfinzi in combination with tremelimumab increased the time patients lived overall compared with standard treatment (sorafenib): patients who received Imfinzi plus tremelimumab (393 patients) lived on average 16.4 months compared with 13.8 months for those who received sorafenib (389 patients). In about 20% of patients who received this regimen, the tumour shrank or disappeared, and this response lasted about 22 months on average. About 5% of patients who received sorafenib had a response to treatment and their response lasted on average 18 months.

When Imfinzi is given alone, the most common side effects (which may affect more than 1 in 10 people) are cough, nose and throat infections, fever, diarrhoea, abdominal (belly) pain, rash, itching and hypothyroidism (an underactive thyroid gland).

When Imfinzi is given together with chemotherapy, the most common side effects (which may affect more than 1 in 10 people) are leucopenia (low levels of white blood cells, including neutrophils which fight infections), anaemia (low levels of red blood cells), nausea (feeling sick), tiredness, thrombocytopenia (low levels of platelets in the blood), constipation, decreased appetite, abdominal pain, hair loss, vomiting, diarrhoea, fever, rash, itching, increased level of liver enzymes and cough.

When Imfinzi is given with tremelimumab and chemotherapy for non-small cell lung cancer, the most common side effects (which may affect more than 2 in 10 people) are anaemia, nausea, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), tiredness, rash, thrombocytopenia and diarrhoea. The most common serious side effects (which may affect more than 1 in 5 people) are neutropenia and anaemia. Other serious side effects (which may affect up to 1 in 10 people) are pneumonia (infection of the lungs), thrombocytopenia, leucopenia, tiredness, neutropenia with fever, colitis (inflammation of the large intestine) and increased levels of liver enzymes and lipase (an enzyme that helps digest fat, mainly made in the pancreas).

When Imfinzi is given with tremelimumab for hepatocellular cancer, the most common side effects (which may affect more than 1 in 10 people) are peripheral oedema (swelling especially of the ankles and feet) and increased level of lipase.

For the full list of side effects and restrictions of Imfinzi, see the package leaflet.

Imfinzi was shown to increase the time patients with locally advanced non-small cell lung cancer lived without their disease getting worse and the time patients with extensive small cell lung cancer or with biliary tract cancer lived overall. In combination with tremelimumab, Imfinzi had beneficial effects in patients with NSCLC and in those with hepatocellular carcinoma. The use of Imfinzi in patients with locally advanced NSCLC is restricted to those whose cancer produces PD-L1, since a clear benefit was only shown in this group of patients. Side effects with Imfinzi were considered manageable, and its safety profile acceptable and in line with that of similar medicines.

The European Medicines Agency therefore decided that Imfinzi’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imfinzi have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Imfinzi are continuously monitored. Side effects reported with Imfinzi are carefully evaluated and any necessary action taken to protect patients.

Imfinzi received a marketing authorisation valid throughout the EU on 21 September 2018.

Imfinzi : EPAR - Medicine overview

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Imfinzi : EPAR - Risk-management-plan summary

Product information

Imfinzi : EPAR - Product information

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Latest procedure affecting product information: IAIN/0060

13/07/2023

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Imfinzi : EPAR - All authorised presentations

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Product details

Name of medicine
Imfinzi
Active substance
durvalumab
International non-proprietary name (INN) or common name
durvalumab
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XC28

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Non-Small Cell Lung Cancer (NSCLC)
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ? 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).

IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.

Small Cell Lung Cancer (SCLC)
IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

Biliary Tract Cancer (BTC)
IMFINZI in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).

Hepatocellular Carcinoma (HCC)
IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Authorisation details

EMA product number
EMEA/H/C/004771
Marketing authorisation holder
AstraZeneca AB

151 85 Sodertalje
Sweden

Opinion adopted
26/07/2018
Marketing authorisation issued
21/09/2018
Revision
17

Assessment history

Imfinzi : EPAR - Procedural steps taken and scientific information after authorisation

Imfinzi-H-C-4771-II-0046: EPAR - Assessment report - Variation

Imfinzi-H-C-4771-II-0045 : EPAR - Assessment report - Variation

Imfinzi-H-C-4771-II-0041 : EPAR - Assessment report - Variation

CHMP post-authorisation summary of positive opinion for Imfinzi (II-45)

CHMP post-authorisation summary of positive opinion for Imfinzi (II-41)

CHMP post-authorisation summary of positive opinion for Imfinzi (II-46)

Imfinzi-H-C-PSUSA-00010723-202104 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Imfinzi-H-C-4771-II-0014-G : EPAR - Assessment Report - Variation

Imfinzi-H-C-PSUSA-00010723-201910 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

CHMP post-authorisation summary of positive opinion for Imfinzi (II-14-G)

Imfinzi : EPAR - Public assessment report

CHMP summary of positive opinion for Imfinzi

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