UK grants patients early access to AbbVie/Roche leukaemia drug

UK patients could have early access to AbbVie/Roche's venetoclax for chronic lymphocytic leukaemia, before the drug is approved by regulators.

The UK's Medicines and Healthcare products Regulatory Agency gave venetoclax, co-developed with Roche's Genentech unit, a positive scientific opinion through its Early Access to Medicines Scheme (EAMS).

Patients with certain types of difficult-to-treat chronic lymphocytic leukaemia (CLL) could gain access to venetoclax, while the European Medicines Agency continues to review the filing.

Through EAMS, venetoclax is indicated for adults with 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).

It can also be used in adults with CLL in the absence of 17p deletion or TP53 mutation, and who are unsuitable for or have failed both chemo-immunotherapy and a BCRi.

EU regulators began reviewing venetoclax in CLL in January, and the drug was conditionally approved by the US Food and Drug Administration in second line in patients with the 19p deletion in April, under the brand name Venclexta.

Thomson Reuters, in a report on blockbusters poised to hit the market in 2016, forecast sales of Venclexta would be almost $1.5 billion by 2020, while other commentators have said the figure may be as high as $2 billion.

Venclexta is also important to AbbVie as the company hopes to combine it with its already approved Imbruvica (ibrutinib), another blood cancer drug it shares with Johnson & Johnson. AbbVie is also developing the drug in acute myeloid leukaemia.

Only four medicines have been made available on EAMS since the scheme began in 2014. It aims to provide access to promising innovative medicines to UK patients who have high unmet clinical need.

The first drug recommended under EAMS was Merck & Co's cancer immunotherapy Keytruda (pembrolizumab) for advanced melanoma.