New ´biologic´ drug made by Seatle Genetics. This targets lymphoma and costs roughly 9,000 pounds or $16,000 US a month. The mean increased survival time in research was 7 months.
The FDA has approved brentuximab vedotin, brand name Adcetris, for the treatment of HL (Hodgkin lymphoma) and ALCL (systemic anaplastic large cell lymphoma). Adcetris consists of a drug and an antibody – an antibody-drug conjugate – the antibody directs the drug to CD30, a target on lymphoma cells.
Adectris was approved under the FDA´s accelerated approval programme. However
the FDA approved Adcetris after evaluating a single-arm clinical trial with only 102 participants. Patients received only Adcetris. The human study´s endpoint was objective response rate – what percentage of participants´ tumours either shrank or disappeared altogether after treatment. 73% of them achieved either a partial or complete response, and responded to therapy for 6.7 months (average).
The systemic ALCL single-arm clinical trial involved only 58 patients. They received only Adcetris. The primary endpoint was the same; Objective response rate. 86% of them achieved either a partial or complete response, and responded for 12.6 months (average).
Side effects seem the usual nausea, fatigue, white cell decline, upper respiratory infection and sickness.