“The problem at the moment is that it takes $1bn [£600m] to get a drug to market and 15 years or more. That is the justification for the pharmaceutical industry charging high prices.
If on the other hand by the time you get to phase 2 you know exactly which patients it is going to work on, you only put those patients through and instead of 10% you get an 80% response rate.
This morning, Seattle Genetics announced that the expected fast track approval from the FDA has been forthcoming for brentuximab vedotin (Adcetris) following the recent unanimous ODAC voting in both refractory Hodgkin Lymphoma (HL) and Anaplastic Large Cell Lymphoma (ALCL). Clearly, the company and the agency have come to agreement on the confirmatory trials as part of the condition of accelerated review. The final prescribing information (PI) can be found on the Adcetris website.
For those of you looking for more information on Adcetris, please check out the related posts section below for previous reports on this novel ADC therapy.
This weekend heralded the sixteenth annual meeting of the European Hematology Association (EHA) conference at the ExCel centre in the London Docklands. Completing back to back ASCO and EHA conferences across two continents will test any delegates stamina!
Like ASCO, this year was a relatively quiet one at EHA, with most of the data already known or presented elsewhere. There were some gems in the program though.
In the latest video highlights I discuss three things that caught my attention:
- Is high dose cytarabine (ara-C) really necessary in AML?
- Brentuximab vedotin in anaplastic large cell lymphomas (ALCL)
Quite a few questions have hit my inbox recently from people wanting to know more about Antibody Drug Conjugates (ADCs) and how they work.
They basically consist of three things:
- Monoclonal antibody
- Cytotoxic agent
The goal is to create a new molecule that essentially is greater than the sum of its parts by making it more targeted, like a guided missile against the cancer cells.