New combination therapy now reimbursed for Australians living with incurable blood cancer

Myeloma Australia and Celgene, a Bristol-Myers Squibb Company

CONSUMER media release

MONDAY, JUNE 1, 2020

FOR IMMEDIATE USE

New combination therapy now reimbursed for Australians living with incurable blood cancer

Australians living with the incurable blood cancer, multiple myeloma1 now have access to a new treatment option with today’s listing of REVLIMID® (lenalidomide) in combination with bortezomib (Velcade) and dexamethasone (RVd) on the Pharmaceutical Benefits Scheme (PBS).2

The three drug regimen will be reimbursed on the PBS for the treatment of all newly diagnosed Multiple Myeloma (NDMM) patients, irrespective of transplant eligibility, from June 1, 2020.2

Known as a triplet therapy, each drug in the RVd combination has a different mechanism of action to kill myeloma cells, and all work together to help fight the disease.3

This announcement coincides with an article just published in Medical Journal of Australia’s MJA Insight, highlighting the importance of maximising first-line therapy for myeloma.4

According to article author, Professor Miles Prince, Clinical Haematologist and Director of Cancer Immunology and Molecular Oncology (Epworth Healthcare, Melbourne): “The typical journey of a patient with myeloma is one of response, remission and relapse,5 so early intervention with first-line treatment options remains the best opportunity to optimise long term patient outcomes.

“While myeloma remains incurable, the survival rate for the disease has significantly improved over the past two decades, with the median survival rate having more than doubled to seven years,.6, 7said Prof Prince

“The listing of these treatments on the PBS is critical to improving patient access, and the reimbursement of an additional first-line therapy option for multiple myeloma is welcomed news.”

Multiple myeloma is an incurable blood cancer that develops from plasma cells, a type of white blood cell found in the bone marrow.8, 9

Representing Australia’s third most common blood cancer (after lymphoma and leukaemia),10, 11 approximately 18,000 Australians are living with multiple myeloma at any given time,1 only half of whom will survive five years post- diagnosis.12

Myeloma Australia CEO, Steve Roach, said today’s PBS listing of RVd is good news for the Australian myeloma community.

“This is the first time in Australia that the major treatment options for myeloma have been reimbursed as a triplet therapy. I’m really pleased that the government and the Pharmaceutical Benefits Advisory Committee (PBAC) have seen the importance of this and would like to congratulate them on reimbursing another treatment option for the Australian myeloma community.

“It’s really important for Australians living with myeloma that they have another treatment option, as improved access to therapy options is what can give families more time with their loved ones,” said Mr Roach.

The incurable nature of multiple myeloma and the likelihood of relapse, may have a psychological impact on patients, who can continue to live in fear even during periods of remission.13, 14

Diagnosed with multiple myeloma in December 2018, wife and mother-to-two, Maria (53) is focused on living long enough to see her children grow up.

“I had absolutely no idea what multiple myeloma was before I was diagnosed. It was such a shock, but I remember thinking my kids aren’t going to lose a mother to this, so let’s get on with it,” said Maria.

“I didn’t know if I was going to die in a month, a year or 10 years – how on earth was I going to tell my kids I had cancer. It was very hard, but we decided to just be upfront and honest.

“My goal along the way has just been to see my kids to grow up, and my objective to do so has been to live long enough for the next treatment option. Today’s reimbursement of another therapy is welcomed news for myself and others living with multiple myeloma,” Maria said.

About multiple myeloma

Multiple myeloma is a cancer that develops from abnormal plasma cells. A plasma cell is a type of white blood cell found in the bone marrow, that forms part of the immune system and helps to protect against infection.6, 10 The abnormal plasma cells crowd the bone marrow and make it difficult to produce enough normal blood cells.10

Multiple myeloma can be challenging to diagnose due to its wide range of symptoms, including high blood calcium levels, anaemia, fatigue, kidney failure, recurrent infections and bone pain.9

Current treatment for multiple myeloma includes a continuous approach, often comprising initial therapy, consolidation maintenance, and salvage therapy.15 Treatment options for multiple myeloma include chemotherapy, corticosteroids, autologous stem cell transplant (ASCT), immunomodulating drugs (IMiDs) monoclonal antibodies therapy, and proteasome inhibitors.16, 17

About REVLIMID® (lenalidomide)

Representing an oral medication approved for the treatment of relapsed myeloma over 10 years ago,18 REVLIMID® is an immunomodulating agent (IMiD) that slows the growth of multiple myeloma plasma tumour cells and proteins known to play a key role in multiple myeloma, delays the development of new blood vessels, and enhances immune function.19

The most commonly reported side-effects of REVLIMID® include diarrhoea, constipation, nausea, vomiting, stomach pain, indigestion, dehydration, dry mouth, mouth ulcer, sore mouth, increase or decrease in weight, increase or decrease in appetite, loss of taste, itchiness, rash, redness of the skin, dry skin, bruising, excessive sweating, dizziness, fainting, headache, shaking or tremors, unusual weakness, night sweats, reduced sense of touch, difficulty sleeping, depression, anxiety, feeling of confusion, back pain, muscle spasms, muscle and/or joint pain, swollen joints, bone pain, muscular weakness, pain in the extremities, feeling tired, falling, swelling of hands, ankles or feet.20

Other possible side effects of REVLIMID® include heart palpitations or fast heartbeat, chest pains, dizziness or fainting, shortness of breath, weakness or reduced ability to exercise, bleeding (including nose-bleeds), bruising more than usual, numbness, tingling, blurred vision or difficulty seeing, passing large amounts of urine, excessive thirst, and having a dry mouth and skin, abnormal eye movements, convulsions, mood changes, irregular heart rhythms or tender swollen lymph nodes.20

All patients receiving REVLIMID® must be registered on, and abide by the requirements of, i-access® risk management program to avoid exposure to unborn babies, due to the potential for birth defects. It is important to note that a small number of patients with multiple myeloma may develop additional types of cancer, regardless of their type of therapy. At this stage, it cannot be excluded that this risk may be slightly increased with REVLIMID® maintenance treatment.20

Disclosure

Celgene supports disclosure and transparency on interactions between the healthcare industry and healthcare professionals to ensure public trust and confidence. No expert spokespeople have been offered compensation for their involvement in this media campaign. All expert spokespeople have been briefed on the approved use of these products and their obligations with regard to promotion to the general public. Prof Miles Prince and Myeloma Australia have received funding from Celgene for projects unrelated to this announcement. All opinions expressed are their own.

About Celgene

Celgene, a Bristol-Myers Squibb Company, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases, through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation.

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