BRIEF—Opdivo gains approval in Australia for advanced bladder cancer

Immuno-oncology therapy Opdivo (nivolumab) has received registration by Australia’s 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, says US pharma major Bristol-Myers Squibb.

The approval of this indication is based on objective response rate and duration of response data in a single arm study, the company noted.

This is the 8th indication for Opdivo in Australia across six cancer areas in just over two years.

The drug generated full-year 2017 global sales of $4.95 billion for B-MS.

It is positive news for affected patients who have seen few advancements in treatment of this disease over the last few decades, said B-MS.

The current five-year survival rate for Australians with bladder cancer is 53%.