We discussed Remdesivir and convalescent plasma in the previous article. In this continuation of the topic, we will discuss monoclonal antibody cocktail(s).

“Compassion” has become an old-fashioned word.  It seems not too many pharmaceutical companies make any decisions based on it anymore.  Allow me to share with you my recent attempts at getting compassionate use program established at one of our largest pharmaceutical companies.

PCI-32765 (ibrutinib) is one of the new generation of targeted kinase inhibitors that is getting a lot of attention.  ASCO 2012 had three important papers on this drug.  So far, so good!  But please make sure you read the Editorial section as well, where I highlight some adverse effect concerns based on feedback I got from people taking this drug.

Last month I was invited to speak at the CLL-PAG conference in Canada.  One of the other speakers was Dr. Mike Keating.  He prophesied that in the next 2-3 years chemotherapy as we know it today will become obsolete and we will begin curing CLL patients without such barbaric & toxic stuff.  Here is the technology that he thinks will do it.

This article reviews an important phase-3, large scale, double arm trial that has just opened for recruiting previously treated patients.  The trial looks to compare CAL-101 + Rituxan vs. Rituxan alone.  Before you sign up, you really, truly need to understand the details of the design of this trial.

Here is a perfect example of a drug therapy regimen that is more dangerous than the disease.  You are all familiar with FCR, the present day gold standard. This French clinical trial substituted Campath in place of of Rituxan.   Big mistake.  Don’t let anyone talk you into this combination – it might kill you sooner than the CLL.

The risk of basal cell carcinoma is significantly higher in CLL patients than in the general public.  Given our immune dysfunction, it is also likely to be more aggressive and harder to treat.  I am pleased to report FDA approval of a brand new drug (“Erivedge“)for aggressive basal cell carcinoma.

This is an important trial – one that we really need to monitor going forward.

Kinase inhibitors such as PCI-32765 are going to play an important role for CLL patients.  How important?  How best to use them? What are realistic adverse effects?  Who is most likely to benefit?  This well designed NIH / NCI clinical trial will help answer these questions – without conflict of interest or good science taking a backseat to commercial hype. We really need this trial.  Merry Christmas to us all! 

PCI-32765 is a very interesting kinase inhibitor drug, similar to CAL-101.  Here is the latest information on this drug presented at ASH2011 (December, 2011) conference.  This and other next generation designer drugs like it may change the whole ballgame for CLL patients living today.