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The FDA approved the PD-1 immune checkpoint inhibitor nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma, the Thursday.

Approval was based on results from the phase III CheckMate-901 trial, which were presented last year at the European Society for Medical Oncology (ESMO) congress. With a median follow-up of about 33 months, the nivolumab-based regimen reduced the risk of death by 22%, with a median overall survival (OS) of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (HR 0.78, 95% CI 0.63-0.96, P=0.0171).

In addition, patients receiving the combination reduced their risk of disease progression or death by 28%, with a median progression-free survival (PFS) of 7.9 months versus 7.6 months with cisplatin-gemcitabine alone (HR 0.72, 95% CI 0.59-0.88, P=0.0012).

"This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer," said Guru Sonpavde, MD, of the AdventHealth Cancer Institute in Orlando, Florida, in a from drugmaker Bristol Myers Squibb. "Based on outcomes and the safety profile seen in the CheckMate-901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable urothelial cancer is treated for certain patients and offers them new hope."

According to Bristol Myers Squibb, this is the first concurrent immunotherapy-chemotherapy combination approved for this patient population in the U.S.

However, the approval comes several months after the FDA approved what is now considered the first-line standard of care -- the antibody-drug conjugate enfortumab vedotin (Padcev) plus the PD-1 inhibitor pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility.

Data from the EV-302/KEYNOTE-A39 trial, also presented at ESMO, demonstrated that OS and PFS both doubled with enfortumab plus pembrolizumab (31.5 and 12.5 months, respectively) versus platinum-containing chemotherapy (16.1 and 6.3 months).

The most common adverse reactions (≥15%) in patients receiving nivolumab with platinum-doublet chemotherapy were nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, peripheral neuropathy, urinary tract infection, diarrhea, edema, hypothyroidism, and pruritus.

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