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FDA Accepts Priority Review for Opdivo Plus Chemo in Bladder Cancer Subtype


The FDA accepted a priority review for the supplemental Biologics License Application of Opdivo with chemotherapy for untreated patients with unresectable or metastatic bladder cancer.

FDA graphic

The U.S. Food and Drug Administration (FDA) has accepted a priority review for the supplemental Biologics License Application of Opdivo (nivolumab) plus cisplatin-based chemotherapy for previously untreated patients with unresectable (cannot be surgically removed) or metastatic urothelial carcinoma, according to a news release.

Opdivo is a type of immunotherapy drug that binds to a protein called PD-1, which helps the immune cells effectively destroy cancer cells. The drug is also a type of monoclonal antibody and immune checkpoint inhibitor, as defined by the National Cancer Institute.

The priority review for the supplemental Biologics License Application was based on results from a phase 3 trial, CheckMate-901. Findings from the trial determined that the Opdivo-cisplatin combination demonstrated positive survival outcomes as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma, a subtype of bladder cancer.

“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 said in the news release. “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 manufacturer of Opdivo.

“We look forward to working with the FDA throughout the review of this application and hope to bring the first immunotherapy-chemotherapy combination to these patients in the U.S. We want to offer a special thanks to the patients and investigators involved in the CheckMate-901 clinical trial,” she said.

The respective trial compared Opdivo plus cisplatin with standard-of-care gemcitabine with cisplatin chemotherapies, according to the news release from Bristol Myers Squibb. Findings from the trial were also presented at the 2023 ESMO Congress.

Specifically, the CheckMate-901 trial evaluated overall survival (OS; length of time from diagnosis or start of treatment when a patient is still alive) and progression-free survival (PFS; length of time during and after treatment when a patient lives with the disease but does not worsen), Bristol Myers Squibb reported.

READ MORE: Opdivo Plus Chemo Provides Survival Benefit in Bladder Cancer Subtype

The median follow-up in the trial was approximately 33 months and established that Opdivo plus cisplatin-based chemotherapy reduced the risk of death by 22%.

The median OS was 21.7 months when patients received the Opdivo-cisplatin combination, versus 18.9 months when receiving chemotherapy alone. After 12 months and 24 months, the researchers found that the OS was 70.2% and 46.9%, respectively for patients receiving Opdivo and cisplatin. After 12 months and 24 months on chemotherapy alone, patients had an OS of 62.7% and 40.7%.

Researchers from the trial also determined that the treatment combination reduced the risk of death or disease progression by 28% and demonstrated a median PFS of 7.9 months versus 7.6 months with chemotherapy alone.

Patients had a median PFS of 34.2% after 12 months and 23.5% after 24 months when receiving Opdivo plus cisplatin. When patients received chemotherapy alone, the PFS rates after 12 months and 24 months were 21.8% and 9.6%, respectively.

The safety profile of Opdivo plus cisplatin was reported to be tolerable and consistent with previous safety profiles regarding each drug individually.

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