Yesterday, the US FDA announced the approval of Seattle Genetics’ antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with chemotherapy for patients with previously treated stage III or IV classic Hodgkin’s lymphoma (cHL). Ovo odobrenje predstavlja poboljšanje u početnom planu liječenja uznapredovalog Hodgkinovog limfoma koji je uveden u kliničku praksu prije više od 40 godina.
Lymphoma is a type of cancer that begins in the lymphatic system. The immune system helps the body fight infections and diseases. Lymphoma can develop almost anywhere in the body and can spread to nearby lymph nodes. It is divided into two types: Hodgkinov limfom and non-Hodgkin lymphoma. Most patients with Hodgkin limfoma belong to the classic type. In this type of lymph node, there are large abnormal lymphocytes (a type of white blood cell). Called Reed-Sternberg cells. Through early intervention, patients with Hodgkin’s lymphoma usually get long-term remission.
U kliničkom ispitivanju potvrđen je potencijal Adcetrisa za liječenje klasičnog Hodgkinovog limfoma - istraživači su regrutirali 1,334 liječenih pacijenta koji su prije toga u prosjeku primali 6 tečajeva od 28 dana. Nakon toga podijeljeni su u dvije skupine, jedna skupina primala je Adcetris i kemoterapiju (AVD), a druga skupina samo kemoterapiju (ABVD). Studije su pokazale da pacijenti koji primaju kombiniranu terapiju imaju 23% manji rizik od progresije bolesti, smrti ili potrebe za započinjanjem novog liječenja u usporedbi s pacijentima koji primaju samo kemoterapiju.
Adcetris combines antibodies and drugs, allowing antibodies to direct drugs to stanice limfoma called CD30, approved for treatment of relapsed classic Hodgkin lymphoma, classic Hodgkin lymphoma with high risk of relapse or progression after stem cell transplantation, accepted Systemic anaplastic large cell lymphoma that other treatments are not effective, and primary cutaneous anaplastic large cell lymphoma that does not work with other treatments.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601935.htm
