Approved
Immunotherapy

durvalumab (IMFINZI®)

Primo-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).

Intervention Type

Biological

Solid/Hematological

Solid

Cancer Type

Lung

Therapy Types

Immunotherapy

Regulatory

FDA

N/A

Regulatory Pathway: n/a

EMA

21.09.2018

Regulatory Pathway: standard approval

Availability in other countries

N/A

Focus Area

Cancer

ASMR

III

Medical Need

Unmet

SMR

IMPORTANT

Orphan Status

No

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