FDA clears Opdivo to treat most common form of bladder cancer

pharmafile | February 6, 2017 | News story | Sales and Marketing BMS, Bristol-Myers Squibb, MSD, bladder cancer, immunotherapy, keytruda, opdivo 

Bristol-Myers Squibb’s Opdivo has acquired another indication – being given the go-ahead for treatment of patients with metastatic urothelial carcinoma. The drug will be administered through intravenous injection for 60 minutes every two weeks.

The treatment will be offered to patients who have experienced disease progression during or following platinum-coated chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The drug is received accelerated approval from the FDA for the new indication based upon data from a Phase 2 trial that included 270 patients. Close to 1 in 5 were found to have some response to treatment with Opdivo, with complete response sitting at 2.6% and a partial response to treatment at 17%.

“Our goal to help more patients is further realized in today’s approval for Opdivo in this population and we are excited that our Immuno-Oncology therapy is now an option and potential hope for these patients,” said Chris Boerner, president of U.S. Commercial, Bristol-Myers Squibb. “This is evidence of our commitment to Immuno-Oncology and to bringing therapies, like Opdivo, to more and more patients in need of additional choices.”

This approval takes Opdivo’s tally of cancers it can be used in the treatment of to 11. This expansion is particularly important as MSD’s Keytruda, its key rival, continues to show promise and begins to rival Opdivo is terms of sales.

Bladder cancer is the fifth most commonly diagnose cancer in the US, with 77,000 diagnoses and 16,000 deaths in previous year. The indication that BMS received is for the most common type, urothelial that accounts for 90% of diagnosed cases.

Ben Hargreaves

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