"Good news, Merck has just announced that it is reapplying for a marketing authorization for cladribine from the EMA."
"I am a big fan of induction therapy, which is why the resurrection of cladribine as a MS treatment is so important to me. The clinical efficacy of cladribine has never been in doubt. Now that the short to intermediate term risk of secondary cancers has been shown to have been driven by the placebo arm of the CLARITY study being an outlier (zero cases) rather than active treatment group being high; redefines the benefit:risk of cladribine. There is little evidence that cladribine increases short- to intermediate -term cancer risk. In addition, since the licensing of alemtuzumab as a 1st-line therapy the regulatory environment has changed. I am sure the regulators will now have a hard time saying no to a cladribine resubmission given that they have recently licensed alemtuzumab for relapsing MS defined clinically or on MRI."
"As far as induction therapies go cladribine tablets are very easy to use; depletion is slow and gentle therefore there is no cell lysis syndrome that you see with alemtuzumab. More importantly the repopulation kinetics of the lymphocyte populations are completely different with cladribine compared to alemtuzumab. There is no B cell overshoot, which may explain the absence of secondary autoimmunity with cladribine. In short cladribine's safety profile as an induction therapy is so, so, much better than alemtuzumab."
"Having thrown the baby out with the bathwater it looks as if the baby is alive and kicking and threatening once again to disrupt the market; at least the induction side of the market for those who favour induction treatments over maintenance-escalation therapies. Maybe it's time for us to run a head-2-head of alemtuzumab vs. cladribine in the NHS? It would have to be a non-inferiority trial; trying to prove that one drug is better than the other may prove too expensive and difficult."
CoI: multiple, Prof G was the principle investigator on the CLARITY study