NorthWest Biotherapeutics Inc (NWBO)

[hmuney]

26 patients with malignant glioma

For exwannabe: Yes, read the application withdrawal letter. Did you read the application details too? I think some other context was missed in your reply.

https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/sitoiganap

*What did the company present to support its application?

The company presented the results of one main study involving 26 patients with malignant glioma, where Sitoiganap was compared with placebo (a dummy treatment), both taken with bevacizumab (another cancer medicine). Patients who received Sitoiganap plus bevacizumab were also given GM-CSF and cyclophosphamide (two medicines to stimulate the immune response). The main measures of effectiveness were how long the patients lived and how long the patients lived without their disease getting worse.

*What did the Agency recommend at that time?

Based on the review of the available information, at the time of the withdrawal, the Agency had concerns and its provisional opinion was that Sitoiganap could not have been authorised for the treatment of glioma.

The Agency had concerns about the way the medicine was produced and the documentation describing the manufacturing process, leading to uncertainties about the quality of the medicine. The Agency also considered that the non-clinical studies did not demonstrate how the medicine is supposed to work in patients with glioma. Adding to these concerns, the results of the main study were not robust enough to show that Sitoiganap was effective at treating patients with glioma, and the safety profile of the medicine could not be established.

Therefore, at the time of the withdrawal, the Agency was not able to draw conclusions on the effectiveness of Sitoiganap in treating glioma and its opinion was that the benefits of Sitoiganap in this use did not outweigh its risks.