EMA Recommends Extension of Therapeutic Indications for Durvalumab and Adopts a Positive Opinion for Tremelimumab

On 15 December 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product durvalumab (Imfinzi).

The marketing authorisation holder for this medicinal product is AstraZeneca AB.

The CHMP adopted a new indication to include Imfinzi in combination with tremelimumab and platinum-based chemotherapy for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK-positive tumours.

The CHMP also adopted a new indication to include Imfinzi in combination with tremelimumab for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

For information, the full indications for Imfinzi will be as follows (new indications in bold):

NSCLC

IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable NSCLC in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy.

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 tumours.

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 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 BTC.

HCC

IMFINZI in combination with tremelimumab is indicated for the firstline treatment of adults with advanced or unresectable HCC.

On 15 December 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal products Tremelimumab AstraZeneca, intended for the treatment of metastatic NSCLC and tremelimumab (Imjudo), intended for the treatment of HCC.

The applicant for these medicinal products is AstraZeneca AB.

Tremelimumab AstraZeneca and Imjudo will be available as a 20 mg/ml concentrate for solution for infusion. The active substance of Tremelimumab AstraZeneca and Imjudo is tremelimumab, a monoclonal antibody (ATC code: L01FX20). It binds to CTLA-4, which is primarily expressed on the surface of T lymphocytes, and thus enhances T-cell activation and proliferation, resulting in increased T-cell diversity and enhanced anti-tumour activity.

The benefits of Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy, in the first-line treatment of metastatic NSCLC, are improvements in overall survival (OS) and progression-free survival compared with standard of care, chemotherapy, as observed in a randomised, open-label phase III study.

The most common side effects are anaemia, nausea, neutropenia, fatigue, rash, thrombocytopenia and diarrhoea.

The full indication is:

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

The benefit of Imjudo in combination with durvalumab is a significant improvement in OS compared with the standard of care, sorafenib, as observed in a randomised, open-label, multicentre phase III study in patients with unresectable HCC.

The most common side effects are rash, pruritus, diarrhoea, abdominal pain, increased AST, pyrexia, hypothyroidism, cough/productive cough, peripheral oedema and increased lipase.

The full indication is:

IMJUDO in combination with durvalumab is indicated for the first-line treatment of adults with advanced or unresectable HCC.

Tremelimumab AstraZeneca and Imjudo should be prescribed by physicians experienced in the treatment of cancer.

Detailed recommendations for the use of these products will be described in the updated summaries of product characteristics, which will be published in the revised European public assessment reports, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion. 

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