Basic Information
Naveruclif
Regulatory Information
EMEA/H/C/006173
January 5, 2024
November 9, 2023
1
March 13, 2025
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Naveruclif monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4). Naveruclif in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Naveruclif in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Overview Summary
Naveruclif is used to treat the following cancers in adults: - metastatic breast cancer, when the first treatment has stopped working and standard treatment including an anthracycline (another type of cancer medicine) is not suitable. ‘Metastatic’ means that the cancer has spread to other parts of the body; - metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine; - non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin, when the patient cannot have surgery or radiotherapy. Naveruclif is a ‘generic medicine’. This means that Naveruclif contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Naveruclif is Abraxane. For more information on generic medicines, see the question-and-answer document here. Naveruclif contains the active substance paclitaxel attached to a human protein called albumin.