CHMP Backs Imfinzi for NSCLC
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 treatment of adults with resectable NSCLC at high risk of recurrence.
The full indications for Imfinzi will therefore be as follow Non-Small Cell Lung Cancer (NSCLC); Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements .
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