CHMP recommends Imfinzi + Imjudo + chemotherapy for first line treatment of NSCLC with no sensitising EGFR or ALK positive mutations
The 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 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 NSCLC with no sensitising EGFR mutations or ALK positive mutations.
For information, the Non-Small Cell Lung Cancer indication for Imfinzi will be as follows: 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 greater than 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 mutations.
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