The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma (UC).

Opdivo is indicated for use along with chemotherapy regimen comprising cisplatin and gemcitabine.

The approval is based on data from the randomised, open-label Phase III CheckMate –901 clinical trial involving 608 patients.

Participants received Opdivo in combination with cisplatin and gemcitabine for up to six cycles, followed by Opdivo monotherapy, or the standard cisplatin-gemcitabine chemotherapy regimen.

Overall survival and progression-free survival were the trial’s primary efficacy endpoints.

After a median follow-up of nearly 33 months, the combination treatment with Opdivo showed a 22% reduction in mortality risk and a 28% decline in disease progression or mortality risk.

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Patients treated with the Opdivo combination therapy experienced a median overall survival of 21.7 months versus 18.9 months for those on chemotherapy alone.

The median progression-free survival was 7.9 months with the Opdivo combination versus 7.6 months with chemotherapy.

The US regulator previously approved Opdivo as an adjuvant therapy for adults with UC with high recurrence risk following radical resection.

It is also approved for treating locally advanced or metastatic UC in patients who had disease progression during or after platinum-containing chemotherapy or saw disease progression within a year of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The supplemental biologics licence application for this new indication of Opdivo received priority review and was approved under the regulator’s Real-Time Oncology Review pilot programme.

Bristol Myers Squibb US haematology and oncology senior vice-president and general manager Wendy Short Bartie stated: “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realisation of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer.

“This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”

Last month, BMS concluded the acquisition of clinical-stage radiopharmaceutical company RayzeBio for $4.1bn.

The companies signed an agreement for the acquisition in December 2023 in which BMS announced plans to acquire all outstanding shares of RayzeBio.