Government funds medicine for aggressive form of lymphoma 1,2

Federal Government funding for a new cancer medicine to treat a rare, aggressive and incurable form of non-Hodgkin lymphoma is being welcomed by medical experts, patients and their families, alongside the Janssen Pharmaceutical Companies of Johnson & Johnson.

The Federal Minister for Health today announced that from 1 August 2018, IMBRUVICA® (ibrutinib) will become the first oral medicine subsidised through the Pharmaceutical Benefits Scheme (PBS) for Australians with Mantle Cell Lymphoma (MCL) whose condition progresses after initial chemotherapy-based treatment*.

The new subsidy will make treatment with IMBRUVICA affordable for hundreds of Australians each year with relapsed or refractory MCL,who face an average survival of only one-to-two years

MCL is a rare and aggressive type of lymphoma1 that typically begins in the immune system’s disease-fighting lymph nodes5 (around the neck, armpits and groin) but can spread to other tissues such as the bone marrow, liver, spleen, gastrointestinal tract and even the spine and brain.

Associate Professor Constantine Tam, Disease Group Lead, Low Grade Lymphoma & CLL at the Peter MacCallum Cancer Centre and Director of Haematology at St Vincent’s Hospital Melbourne, and one of the doctors involved in clinical trials of IMBRUVICA, welcomed the new subsidy noting that, unlike many other forms of non-Hodgkin lymphoma, MCL has a very poor prognosis.

“MCL is both aggressive and incurable, meaning that even if you manage to achieve remission, the vast majority of patients will relapse,”  explained Dr Tam.

“Most types of cancers I treat are either aggressive but potentially curable, or incurable but not aggressive.

There is a clear and present need for affordable access to treatment for MCL patients for whom chemotherapy has stopped working,”  he said. “Until now, there has been no standard of care for these patients. 1This PBS listing provides a new treatment option, which allows us to keep fighting the cancer when chemotherapy stops working.” 

IMBRUVICA works by blocking a protein in the body that helps cancer cells live and grow.

This protein is called Bruton’s tyrosine kinase.

Blocking this protein may help kill and reduce the number of cancer cells and also slow the spread of the disease. 

Sharon Winton, CEO of Lymphoma Australia, said the PBS listing of IMBRUVICA for MCL was “great news for hundreds of Australians with limited treatment options”.

“Many Australians with this aggressive form of lymphoma have been waiting for a viable new treatment option,” she said. “This medicine has been studied extensively, both here in Australia and overseas, and we are delighted that it will become more accessible to patients with MCL.

Minister Hunt is to be commended for ensuring there was no delay in acting upon the experts’ advice and making IMBRUVICA available on the PBS for MCL patients,” she added. Mr Bruce Goodwin, Managing Director, Janssen Australia and New Zealand (Janssen-Cilag Pty Limited), also commended the Turnbull Government on its significant investment in extending the PBS listing of IMBRUVICA to now include the treatment of patients with relapsed or refractory MCL. “This is an important moment in the treatment of mantle cell lymphoma.

We are pleased to support the Federal Government’s efforts to address this area of serious medical need and will continue to work with them, as well as doctors and healthcare organisations, to improve the treatment of blood cancers in Australia,”

Mr Goodwin said. IMBRUVICA was made available on the PBS in 2017 for patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) who are relapsed or refractory to at least one prior therapy and who are unsuitable for treatment with fludarabine.

It will now become available on the PBS on 1 August 2018 for patients with MCL who are relapsed or refractory to at least one prior therapy. About Mantle Cell Lymphoma 

MCL is a clinically aggressive form of non-Hodgkin lymphoma with a median overall survival of 4-5 years.  Up to 450 Australians will be diagnosed with MCL in 2018.

The disease is two-to-three times more common in men than women.  As MCL typically involves the lymph nodes, the first sign of the disease is usually a painless swelling in the neck, armpit and/or groin.

Other symptoms may include abdominal bloating, nausea, tiredness, loss of appetite, fevers, unexplained weight loss and night sweats.• Most patients are diagnosed at an advanced stage of the disease, where the cancer has spread to their organs (e.g. spleen, liver, bowel or brain).

The majority of patients relapse after initial chemotherapy, at which point they have an average survival of one-to-two years.1 About IMBRUVICA

IMBRUVICA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK). It is an oral capsule taken daily until disease progression.

IMBRUVICA is indicated for the treatment of: adult patients with MCL who have received at least one prior therapy; adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) who have received at least one prior therapy or adult patients with previously untreated CLL/SLL; patients with CLL/SLL with 17p deletion; or adult patients with Waldenstrom’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first-line treatment for patients unsuitable for combination chemo-immunotherapy.

Like all medicines, IMBRUVICA can cause side effects. The most common side-effects seen in clinical trials include diarrhoea; feeling very tired; nausea; headache; swollen hands, ankles or feet; being short of breath; dizziness; constipation; infected nose, sinuses or throat (cold); fever; vomiting; decreased appetite; low number of a neutrophils (neutropenia); low number of platelets (thrombocytopenia) and low number of red blood cells (anaemia); bruises; skin rash; muscle and joint pain and low blood sodium levels.

IMBRUVICA is contraindicated in patients who have known hypersensitivity (are allergic) to ibrutinib or its ingredients. Do not use preparations containing St. John’s Wort while you are taking IMBRUVICA. 

Warfarin or other vitamin K antagonists should not be administered concurrently with ibrutinib. Fish oil and vitamin E preparations should be avoided. Use in patients requiring other anticoagulants or medications that inhibit platelet function may increase the risk of bleeding. Heart problems: Irregular heart beat (atrial fibrillation) and high blood pressure have been reported in patients treated with ibrutinib.

Isolated cases of leukostasis (an increase in the number of white blood cells) have been reported in patients and patients should be monitored for fever, neutropenia (an abnormally low count of a type of white blood cell), and infections and appropriate anti-infective therapy should be instituted as indicated.

 

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