Europe: Oncology Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023
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On the 23rd of June 2023, CHMP released its meeting highlights for the month of June. The main discussion points of the meeting are as follows:
Positive Recommendations on Extensions of Indications
Imjudo (tremelimumab) - AstraZeneca AB
Indication: The CHMP adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Imjudo for a new indication for the treatment of metastatic non-small cell lung cancer as below:
- Imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
Lonsurf (trifluridine / tipiracil) - Les Laboratoires Servier
Indication : The CHMP adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lonsurf for a new indication for the third-line treatment of colorectal cancer in combination with bevacizumab as below:
- Lonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.
Notification link: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023
Document Link: