Janssen and AbbVie’s Imbruvica combination recommended by NICE for leukaemia

The Janssen Pharmaceutical Companies of Johnson & Johnson and AbbVie’s Imbruvica (ibrutinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as part of a combination treatment for patients with untreated chronic lymphocytic leukemia (CLL).

CLL is the common type of leukaemia in adults, with around 3,800 people in the UK diagnosed with the disease each year.

While patient outcomes have dramatically improved in the last few decades, CLL is ultimately incurable and patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

Imbruvica works by blocking the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread.

NICE’s decision was based on clinical evidence showing the drug, in combination with Roche and AbbVie’s Venclyxta (venetoclax), slowed disease progression longer than other approved treatments for CLL and caused fewer side effects.

Amanda Cunnington, director of patient access at Janssen-Cilag Limited said: “The availability of this combination therapy will bring a much-needed new treatment option for those living with CLL, and Janssen is proud to have added to our existing ibrutinib-based treatment options for patients across England and Wales.

“We look forward to seeing eligible patients benefit from this treatment, and remain committed to advancing innovations in blood cancer across the world.”

Hilary Lindsay, chair of CLL Support said the approval marked a “great step forward” in the treatment of CLL, adding that it will “prove to be of huge benefit to patients”.

Imbruvica is already used in the NHS as a solo treatment or in combination with obinutuzumab or rituximab for previously untreated CLL. It is also authorised for use as a single agent or in combination with bendamustine and rituximab for CLL patients who have received at least one prior therapy.

The drug is up against BeiGene’s rival BTK inhibitor, Brukinsa (zanubrutinib), which was granted two new marketing authorisations earlier this year by the Medicines and Healthcare products Regulatory Agency to treat CLL, as well as patients with marginal zone lymphoma – a group of ultra-rare, slow growing B-cell malignancies – who have received at least one prior anti-CD20-based therapy.