‘Game-changing’7-9 leukaemia treatment approved

‘Game-changing’7-9 leukaemia treatment approved

A new breakthrough9 cancer-fighting therapy that significantly improves survival1-3 in the most common form of leukaemia4 has received regulatory approval in New Zealand.

The oral once-daily treatment, IMBRUVICA® (ibrutinib), has been approved by Medsafe, New Zealand’s medicines regulator, to treat New Zealanders with chronic lymphocytic leukaemia (CLL) whose disease has progressed despite other treatment.3

CLL is a life-threatening disease and one of the most rapidly growing cancers in New Zealand, with around 120 cases being diagnosed every year.4

IMBRUVICA® is the first of a new class of highly-targeted therapies called Bruton’s Tyrosine Kinase inhibitors, which work by blocking signals to the leukaemia cells to multiply and spread. Clinical trials show a 78 percent reduction in progression or death of previously-treated CLL patients receiving IMBRUVICA®, compared with those on a commonly-used second-line treatment.1-3

Dr Ken Romeril, consultant haematologist at Wellington Blood and Cancer Centre, which has been involved in IMBRUVICA® clinical trials, said many patients on conventional CLL treatments simply run out of options.

“Most CLL patients are aged over 60, and current treatment options such as chemotherapy can be very taxing while offering only a temporary reprieve,”1-2 said Dr Romeril.

Clinical trials show IMBRUVICA® inhibits the cancer even in heavily previously-treated elderly patients and that, importantly, it is also well tolerated.1-2 The new therapy is being described as a fundamental change in the treatment of CLL, and a life-changer for patients.5-7

A further significant benefit of IMBRUVICA® in the management of CLL is that patients take their medicine at home each day, rather than in cycles of chemotherapy delivered in a hospital setting, which lessens their exposure to hospital-acquired infections and changes the treatment approach to one of managing a chronic illness.7

At Auckland’s North Shore Hospital, which has also been involved in clinical trials of IMBRUVICA®, patient response rates were described as “unprecedented and durable”.

IMBRUVICA® has also been approved in New Zealand as a first-line treatment for CLL patients with a rare chromosome anomaly known as 17p deletion, meaning they are missing certain tumour-suppressing genes.3

Patients with this anomaly have the greatest unmet need among CLL patients, and for them IMBRUVICA® is a highly significant breakthrough9, providing them for the first time with treatment that’s approved specifically for use in 17p deletion patients.3

Dr David Simpson, Senior Specialist Haematologist at North Shore Hospital, said that the challenge for New Zealand as more of these new breakthrough therapies come onto the market is how to fund them.

“These medicines are expensive, and we don’t want rationing by delay. So we need to work out ways to sustainably fund the new therapies that are changing the way we treat cancer. The question is no longer how do we treat cancer, but how do we fund these new treatments” said Dr Simpson.

Janssen-Cilag Pty Ltd (Janssen), the company that brought IMBRUVICA® to New Zealand, confirmed that a submission to include the therapy for funding on the Pharmaceutical Schedule for relapsed/refractory CLL was considered by PTAC at its November meeting.

Janssen Managing Director, Chris Hourigan, said Janssen is committed to working closely with Pharmac so that all patients can have funded access to the therapy at the earliest possible opportunity.

“In the meantime, we’ve included New Zealand in our global early access programme to ensure patients who have an immediate need and meet clinical criteria can access this potentially life-changing treatment,” said Mr Hourigan.

IMBRUVICA® is a prescription medicine that has risks and benefits. The most common side effects experienced with IMBRUVICA® are diarrhoea, vomiting, stomatitis, nausea, constipation, pneumonia, upper respiratory tract infection, sinusitis, neutropenia, thrombocytopenia, anaemia, rash, arthralgia, musculoskeletal pain, dizziness, headache; haemorrhage, bruising, petechiae, pyrexia, and peripheral oedema.3

IMBRUVICA® recently won the prestigious Prix Galien USA 2015 Award in the category of Best Pharmaceutical Agent. The Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical and medical technology research, honouring significant advances in pharmaceutical research.8

IMBRUVICA® received Breakthrough Therapy Designation from the U.S. Food and Drug Administration in July 2014.9

ENDS

© Scoop Media