FDA Approves Opdivo Plus Chemo for Unresectable or Metastatic Bladder Cancer

The Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with the chemotherapy drugs cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma, the agency has announced.

Efficacy of the treatment was established in the phase 3 CHECKMATE-901 trial of 608 patients with previously untreated unresectable or metastatic urothelial carcinoma who received either Opdivo and cisplatin and gemcitabine for up to six cycles followed by standalone Opdivo for up to two cycles, or up to six cycles of cisplatin and gemcitabine. Patients in both arms who discontinued treatment with cisplatin were permitted to receive carboplatin, according to the agency.

The priority review of the combination was accepted at the end of 2023.

“The FDA’s acceptance of our application for Opdivo in combination with cisplatin-based chemotherapy represents important progress toward addressing the unmet need for options that may offer durable responses and improved survival for patients with metastatic urothelial carcinoma,” Dr. Dana Walker previously said in the news release announcing the priority review. “There remains a clear need for efficacious first-line treatment options that may potentially help improve outcomes for patients with this hard-to-treat disease.”

Walker is the vice president and global program lead for gastrointestinal and genitourinary cancers at Bristol Myers Squibb, the manufacturing company of Opdivo.

The combination resulted in benefits in both overall survival (OS, the time a patient lives following treatment regardless of disease status) and progression-free survival (PFS, how long a patient lives without their disease spreading or worsening). The median OS was 21.7 months for patients who received Opdivo and 18.9 months for patients who did not, while the median PFS times were 7.9 months and 7.6 months, respectively.

The most common side effects occurring in at least 15% of patients receiving the treatment combination were nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, peripheral neuropathy (numbness and pain in hands and feet), urinary tract infection, diarrhea, edema, hypothyroidism and pruritis.

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