TAFINLAR + MEKINIST is first treatment targeting BRAF gene mutation to be reimbursed for patients

Novartis Australia

• Australia has one of the highest rates of melanoma in the world – 11 times higher than the worldwide average1,2

• Whilst survival rates for those with early stage disease are very high,3,4 without treatment nearly one in two people with Stage IIIB-D melanoma at diagnosis will experience a recurrence within one year of surgery5
• TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib) will be listed on the Pharmaceutical Benefits Scheme (PBS) from 1st November for patients with BRAF V600 mutation positive Stage IIIB, Stage IIIC or Stage IIID melanoma following surgical removal of their tumour, to reduce the risk of this most deadly of all skin cancers coming back6
Sydney, 2019 – Novartis is pleased to announce TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib) has been listed today on the Pharmaceutical Benefits Scheme (PBS) as an adjuvant therapy for patients with BRAF V600 mutation positive, resected (surgically removed) Stage IIIB, Stage IIIC or Stage IIID melanoma.
Incidence of melanoma in Australia is more than twice the rate in the UK or USA.7 It is estimated 15,229 Australians will be diagnosed with melanoma in 2019, and approximately 400 will have Stage III resected BRAF mutation positive melanoma.8 Stage III melanoma means that cancer cells have spread into skin, lymph vessels or lymph glands close to the melanoma but they haven’t spread to other parts of the body. Whilst those diagnosed with Stage I and II melanoma have a very high chance of survival,3,4 nearly one in two people diagnosed with Stage III melanoma will have their cancer return within one year after surgery.5 Until now there have been no reimbursed treatments for these patients.
TAFINLAR and MEKINIST, known as targeted therapies, work on different proteins involved in tumour cell growth that are active in patients with a melanoma carrying the BRAF gene mutation. By targeting and blocking growth signals from these proteins, TAFINLAR and MEKINIST can slow down or stop cancer growth.9,10
Victoria Beedle, CEO of Melanoma Patients Australia said “We know many people with Stage III melanoma are anxious about their cancer returning after their surgery. We welcome the availability of a new treatment option for people following surgery with BRAF-positive disease”.
Determining whether a person is eligible for TAFINLAR in combination with MEKINIST requires a test to confirm the presence of the BRAF V600 mutation. From the 1st November, people with Stage IIIB-D resected melanoma will also have reimbursed access to this test via the Medicare Benefits Schedule (MBS).11
Dr Andrew Haydon, Medical Oncologist at The Alfred Hospital, Melbourne said “As our understanding of the specific characteristics of people’s cancer evolves, so does the development of treatment options that specifically target their disease.
“We now have the ability to identify a certain population of people whose melanoma has a specific genetic mutation – in this case BRAF V600 – and the opportunity to offer them a reimbursed treatment option that targets this specific genetic profile earlier in their cancer journey.”
“This is an important outcome for patients living with BRAF mutation positive Stage IIIB-D melanoma following surgery,” said Lauren Carey, Country President & Oncology General Manager, Novartis Australia & New Zealand. “We acknowledge the Australian Government for their commitment to providing access to innovative therapies for patients in Australia.”
Important Safety Information
Very common side effects of trametinib when used in combination with dabrafenib include: fever, chills, fatigue, decreased appetite, headache, cough, sore throat and runny nose (nasopharyngitis), nausea, vomiting, diarrhoea, constipation, abdominal pain, skin effects (rash, thickening of the skin, dry skin, itching, acne-like problems), sore throat or mouth ulcers due to infections, coughing up blood or blood clots, vomit that contains blood or vomit that looks like “coffee grounds”, bleeding from the nose, or red or black stools (signs of bleeding), swelling in the eye by fluid leakage causing a blurred vision, difficult or painful breathing, cramping diarrhoea with or without blood in stool, abdominal pain as signs of an inflammation of the inner lining of the colon (colitis), severe stomach pain, chills, fever, nausea and vomiting as signs of a hole forming all the way through the stomach, large bowel or small intestine (signs of gastrointestinal perforation), excessive thirst, dark urine, increase appetite with weight loss, irritability as signs of high level of sugar (glucose) in the blood (signs of hyperglycaemia), high or low urine output, drowsiness, confusion, or nausea as signs of an inflamed kidney (nephritis), dry mouth, abnormal growth of cancerous cells of the skin, sensation of flashing light, loss of vision (signs of retinal detachment), acute severe upper stomach pain (sign of pancreatitis), severely decreased urine output (signs of renal failure), joint or muscle pain, pain in extremity, muscle spasms, flu-like symptoms, high or low blood pressure, haemorrhage, swelling of feet or legs (signs of cardiac failure), changes to some liver function tests, and blood sugar levels.
Consumer Medicine Information (CMI)
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