Opdivo (nivolumab) Approved for Australian Patients with Advanced Bladder Cancer

Thursday 15th February 2018

Bristol-Myers Squibb welcomes the registration of its immuno-oncology therapy, OPDIVO® (nivolumab), by the Therapeutic Goods Administration (TGA) as a monotherapy for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy.  The approval of this indication is based on objective response rate and duration of response data in a single arm study.

Checkmate-275 was a single arm interventional study of OPDIVO given intravenously every two weeks to 270 study participants with locally advanced unresectable or metastatic urothelial cancer with disease progression during or after platinum-containing chemotherapy. The objective response rate in the study was 20.4% and the median duration of response 17.7 months1.  In the pooled dataset of nivolumab 3 mg/kg as monotherapy across tumour types, the most frequent adverse reactions (10%) were fatigue (30%), rash (17%), pruritus (13%), diarrhoea (13%) and nausea (12%). The majority of adverse reactions were mild to moderate (Grade 1 or 2). Immune related adverse reactions may occurwith OPDIVO1.

Professor Ian Davis, Medical Oncologist and Professor of Medicine at Monash University and Eastern Health, welcomed the news that bladder cancer patients will now have access to a new option saying, "The registration of OPDIVO for the treatment of advanced bladder cancer in Australia is a positive step forward as there have been few advancements in treatment of this disease over the last few decades. Today's announcement means Australian clinicians will now have an additional therapy to treat patients with advanced bladder cancer who aren't responding to chemotherapy."

"Immuno-oncology agents are redefining the way we are able to treat cancer around the world. These new medicines actually harness the body's own immune system to help fight cancer. Not everyone benefits, but sometimes responses can be striking and prolonged," said Professor Davis.

In 2017, there were 2,995 new cases of bladder cancer diagnosed in Australiaand 1,172 deaths2. Currently, the five-year survival rate for Australians with bladder cancer is 53%2. This means more than four in ten people diagnosed will succumb to the disease during this time. While the relative survival for most other cancers has improved in Australia, for bladder cancer this has decreased over time2.

Bladder cancer is common in people aged over 60 and is significantly more common in men than in women3.  

The TGA registration of OPDIVO, a PD-1 immune checkpoint inhibitor, for bladder cancer marks the eighth indication to be approved in Australia, across six cancers in just over two years, including advanced melanoma, advanced lung cancer, advanced kidney cancer, head and neck cancer, bladder cancer and relapsed/refractory classic Hodgkin lymphoma.1


Brent Pfeiffenberger, General Manager for Bristol-Myers Squibb Australia and New Zealand, says the company is committed to changing survival expectations and the way Australians live with advanced cancer.

Securing the 8th indication for OPDIVO in just over two years, is an important step forward in improving the lives of these cancer patients, and confirms our commitment to changing the way cancer is being treated across Australia, said Mr Pfeiffenberger.


About OPDIVO's safety

OPDIVO is administered as an intravenous infusion every 2 weeks, based on a patient's body weight (3mg/kg).Treatment with OPDIVOcontinues for as long as the patient keeps benefitting from it or can no longer tolerate the treatment.1  OPDIVO acts 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.4

The most frequent adverse events reported for OPDIVO included fatigue, rash, pruritus, diarrhoea and nausea.1

Further information about OPDIVO can be found in the Consumer Medicine Information.

About Immuno-Oncology (I-O)

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.4 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.4


About bladder cancer

Bladder cancer occurs when abnormal cells in the bladder grow and divide in an uncontrolled way and can include different types of disease such as urothelial carcinoma (the most common form of bladder cancer), squamous cell carcinoma and adenocarcinoma5.

In 2017, there were an estimated 2,995 cases of bladder cancer diagnosed in Australia2 and an estimated 1,172 deaths. The five-year survival rate for Australians with bladder cancer is 53%2.

Some of the risk factors for bladder cancer include smoking, diabetes, family history, chronic inflammation of the bladder and workplace exposure to certain chemicals used in textile, petrochemical and rubber industries2.


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