The EBMT welcomes the position adopted by EMA, as it is an intermediary step to making these drugs accessible to patients.
The European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) recommended granting marketing authorisations for two new medicines recommended granting marketing authorisations for two new medicines: Imbruvica (an orphan drug used as treatment for mantle cell lymphoma after relapse or when other treatments haven’t been successful) and Zydelig (a medicine used for adult patients with follicular lymphoma that has not responded to two previous treatments). In cancers targeted by these two drugs, B-lymphocites multiply too quickly and live far too long. This is the case of Chronic Lymphocytic Leukemia, follicular lymphoma and mantle cell lymphoma. All three of them are rare forms of cancer that are assigned treatment with haematopoietic stem cell transplantation.
Imbruvica and Zydelig have the potential to bring new treatment options for patients suffering from these rare cancers, especially in cases where previous treatments have stopped working, as they act through different mechanisms. Imbruvica acts against the abnormal B-lymphocites by blocking the action of Burton’s tyrosine kinase and Zydelig does the same by blocking PI3K-delta, an enzyme regulates growth, migration and survival of white blood cells. The CHMP will now present this resolution to the European Comision for the adoption of a decision on EU-wide marketing approvals. This will lead to decisions on the price and reimbursement at the level of each Member State.