FDA places a partial hold on all venetoclax clinical trials for multiple myeloma (MM) patients
This is very good news for my fellow CLL patients with 17p deletion. It means that venetoclax, better known to many of us as ABT-199, now should be available to those who might benefit from it much sooner.
Quoting from the FDA: “Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions”.
For more details on the FDA’s breakthrough therapy designation you can go to their FAQ page here.
A nice review of the brief history of this new form of FDA fast tracking and what drug already have been approved can be found here.
This is the same path followed by 4 prior drugs to now used to treat CLL: Gazyva (obinutuzumab) in November 2013, Arzerra (ofatumumab) in April 2014, Zydelig (idelalisib) in July 2014 and Imbruvica (ibrutinib) which was specifically for CLL patients with 17p deletion in late July 2014.
As was the case with Imbruvica, the breakthrough designation is only for 17p deletion. Those of us saddled with a 17p deletion in our CLL clone usually carry a particularly challenging prognosis. It is too often a noxious mix of being an aggressive form of CLL, hard to kill cancer cells, and genomic instability. The last item means that it can and does mutate past the control of many medications, leading to an even more difficult to treat cancer.
Having the possibility of more choices for 17p soon is always good news.
Having the possibility of combining drugs into non-chemo cocktails may prove to be an even more attractive option. Such trials are already beginning.
See here for the official press release from Abbvie.
Brian Koffman 5/6/15
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