The FDA announced Breakthrough Therapy Designation (BTD) for acalabrutinib (Calquence) as a single agent to treat chronic lymphocytic leukemia (CLL)
Venetoclax (Venclexta®), will be added to Australian Pharmaceutical Benefits Scheme (PBS) starting March 1, 2019.
Venetoclax was developed in Australia and though it has been approved for use since 2017 this announcement means that it will now be paid for by the government insurance in the country of its birth.
Venetoclax will be available in combination with rituximab for patients aged 18 years or older with relapsed or refractory chronic lymphocytic leukaemia (CLL), who have received at least one prior CLL therapy and who are unsuitable for treatment or retreatment with a purine analogue.
Venetoclax is based on the Australian and other country’s basic science research on BCL-2, a molecule that sends a message to cells to not die. BCL-2 is overproduced in CLL helping CLL cells survive even when they are damaged and should die. Venentoclax blocks BCL-2 leading to rapid killing the CLL cells.
It was proven to be a very effective therapy in CLL, both in the frontline and relapsed setting. It works on those with or without 17p deletion and works even better when combined with other drugs used to treat CLL such as rituximab, ofatumumab and ibrutinib.
While this is great news, it is sad that it was so slow in coming when there has been evidence of its safety and efficacy for at least a few years now. How many patients suffered or even died waiting for this approval?
I suspect that its high cost was the reason that delayed it’s getting on the formulary.
This is a recurrent and ongoing tragedy all over the world, which is another reason to celebrate this victory for patients.
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