Posted by Michael Wonder on 24 Jun 2016
New cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer
24 June 2016 - Orphan medicine Zalmoxis recommended by CAT and CHMP for marketing authorisation
The EMA has recommended granting a conditional marketing authorisation in the EU for a new advanced therapy medicinal product.
Zalmoxis is recommended as an adjunctive, or add on, treatment for adult patients receiving a haploidentical haematopoietic stem cell transplant (HSCT) for various types of blood cancer to aid immune reconstitution and reduce the risk of graft-versus-host disease.
Haploidentical HSCT involves a patient receiving haematopoietic stem cells (non-specialised haematopoietic cells that can develop into different specialised types of blood cell) from a partially matched donor to help the bone marrow produce healthy blood cells. This type of transplant is used to treat serious blood diseases, such as haematological malignancies, that include leukaemia and lymphoma. Transplants from partially-matched donors are more readily available than perfect matches, but carry a higher risk of graft-versus-host disease, where transplanted cells attack the recipient’s organs, leading to organ damage.
For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002555.jsp&mid=WC0b01ac058004d5c1
