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OPDIVO + YERVOY PBS-listed for treatment of early metastatic melanoma recurrence


Bristol Myers Squibb Australia (BMS) is today welcoming the expanded Pharmaceutical Benefits Scheme (PBS) reimbursement of OPDIVO (nivolumab) plus YERVOY (ipilimumab) to include patients with unresectable Stage III or IV malignant melanoma who have experienced disease recurrence whilst on, or within, six months of completion of adjuvant PD-1 inhibitor treatment.


According to Professor Georgina Long AO, Co-Medical Director of Melanoma Institute Australia (MIA), Sydney, the listing helps to address a significant unmet clinical need for high-risk patients.


“Prior to today’s listing, melanoma patients who recurred while on, or within 6 months of, adjuvant anti-PD-1 therapy had limited treatment options, and were unable to access PBS-funded standard of care when they recurred, representing a high unmet clinical need,” said Prof Long. 


“Today’s PBS announcement is a significant milestone for the melanoma community, and as clinicians, we welcome the availability of an additional treatment option for this patient group.”

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Despite the significant advancements in the melanoma treatment landscape, Australia still has one of the highest incidence rates of melanoma in the world. It remains the nation’s third most commonly diagnosed cancer, estimated to claim approximately 1,300 lives every year.


According to Leah Goodman, General Manager, Bristol Myers Squibb Australia, Melbourne, the support provided by the broader melanoma community was paramount in this PBS submission. 


“BMS Australia acknowledges the collective efforts of the Medical Oncology community, patients, carers, and patient organisations who contributed to, and advocated for this listing. 


“This PBS reimbursement provides broad, and equitable access to immunotherapy options for metastatic melanoma patients. We are proud of our efforts to address this unmet medical need, shaping the market to drive change for these most at risk patients,” Ms Goodman said. 


About Immuno-Oncology 


Immuno-oncology is based on the premise that the immune system is the body’s most powerful and effective tool for recognising and fighting disease. Immuno-oncology treatments are designed to harness the patient’s own immune system to combat cancer, by targeting the same immune pathways that tumour cells use to evade recognition and destruction.


About OPDIVO®

OPDIVO is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to harness the body’s own immune system, to help restore anti-tumour immune response.4 By harnessing the body’s own immune system to fight cancer, OPDIVO has become an important treatment option across multiple cancers.4  OPDIVO’sleading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumour types. In Australia, OPDIVO was approved in January 2016, and is now approved in  more than 65 countries, including the United States, the European Union, and Japan.  The Company’s OPDIVO and YERVOY combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma, and is currently approved in more than 50 countries, including Australia, the United States, and the European Union.


About YERVOY®


YERVOY is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).5 CTLA-4 is a negative regulator of T-cell activity.5 YERVOY binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86.5 Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumour infiltrating T-effector cells.5 Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumour immune response. YERVOY is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for YERVOY spanning multiple tumour types.


About OPDIVO® and YERVOY® combination safety4, 5


Both OPDIVOand YERVOYact on the immune system and may cause inflammation. Inflammation may cause serious damage to a patient’s body, and some inflammatory conditions may be life threatening. The very common (>10%) adverse events observed with OPDIVO in combination with YERVOY were headache, rash, pruritis, dyspnoea, fatigue, pyrexia, hypothyroidism, colitis, diarrhoea, vomiting, nausea, abdominal pain, arthralgia, and decreased appetite.Increased AST, ALT, total bilirubin, alkaline phosphatase, lipase, amylase and creatinine; hyperglycaemia, hypoglycaemia, lymphopaenia, leukopaenia, neutropaenia, thrombocytopaenia, anaemia, hypocalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia and hyponatraemia are also very common.


Disclosure


Bristol-Myers Squibb 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 this product and their obligations with regard to promotion to the general public. 


About Bristol-Myers Squibb™ 


Bristol-Myers Squibb™ is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb™, visit us at BMS.com/au or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. 

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