The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted an Early Access to Medicines Scheme (EAMS) positive scientific opinion to potent anti-cancer treatment venetoclax for use in patients with difficult-to-treat chronic lymphocytic leukaemia (CLL).
Venetoclax was co-developed by US pharmaceutical companies AbbVie and Roche group member Genentech, and discovered by AbbVie scientists as part of a joint research collaboration with scientists of Walter and Eliza Hall Institute, Melbourne.
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The EAMS opinion will enable adult patients in the UK to gain access to the drug to treat CLL in the presence of 17p deletion or TP53 mutation, and who are unsuitable for or have failed a B-cell receptor pathway inhibitor (BCRi).
Venetoclax is designed to target the B-cell lymphoma-2 (BCL-2) protein and enable the body’s ability to trigger cancer cell self-destruction (apoptosis). BCL-2 protein regulates cancer cell survival.
More than 3,000 new cases of CLL are recorded in the UK each year.
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Trials were successfully conducted in Melbourne, Australia, and during this the drug was found to be effective in killing cancer cells within approximately 80% of people with very advanced forms of CLL, while 20% of patients achieved a complete remission.
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By GlobalDataWalter and Hall Institute clinical haematologist and clinical translation head professor Andrew Roberts said the trials showed that patients responded to venetoclax with a very substantial reduction of leukaemia cells in their body.
Roberts said: “Some patients have remained in remission four years after their treatment began.
“In many cases we have seen the cancerous cells simply melt away.”
Roberts further noted that even very sensitive research tests were unable to detect any remaining leukaemia in the patients’ bodies.
In April this year, the US Food and Drug Administration (FDA) granted approval to the drug for use in patients with CLL who have a specific chromosomal abnormality, known as a 17p deletion, and who have been treated with at least one other therapy.
The drug is currently under review by the European Medicines Agency (EMA).
