Meeting highlights from the CHMP: Oncology - 7-10 November 2022

On the 11th of November 2022, CHMP released its meeting highlights for the month of November. The main discussion points of the meeting included the following:

Recommendations on extensions of therapeutic indication

Enhertu (trastuzumab deruxtecan) - Daiichi Sankyo Europe GmbH

• Indication: a medicine used to treat breast cancer that is metastatic (has spread to other parts of the body) or cannot be removed by surgery.
• Positive CHMP recommendation on extension of indications

Imfinzi (durvalumab) - AstraZeneca AB

• Indication: a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
• Positive CHMP recommendation on extension of indications

Lynparza (olaparib) - AstraZeneca AB

• Indication: a medicine used to treat adults who have advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene.
• Positive CHMP recommendation on extension of indications

Withdrawals of applications

Gavreto (pralsetinib) - Roche Registration GmbH

• Indication: a cancer medicine for treating adults with advanced non-small cell lung cancer caused by changes in a gene called RET (known as RET fusion-positive NSCLC) and who have not been treated with a RET inhibitor.
• Applications for extensions of therapeutic indications were withdrawn.

Febseltiq (infigratinib) - Helsinn Birex Pharmaceuticals Ltd

• Indication: treatment of cholangiocarcinoma.
• Applications for marketing authorisation were withdrawn.

Notification link: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022