FDA Greenlights Opdivo Combination Therapy for First-Line Bladder Cancer Treatment
1. The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb's Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).
2. This approval is based on positive results from the Phase 3 CheckMate -901 trial, which showed a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared to cisplatin-gemcitabine alone.
3. Median OS for patients receiving Opdivo in combination with cisplatin and gemcitabine was 21.7 months, while those receiving cisplatin-gemcitabine alone experienced a median OS of 18.9 months.
4. The Opdivo combination is the first concurrent immunotherapy-chemotherapy combination approved for this patient population in the U.S..
5. Despite the approval, Opdivo faces competition from Keytruda (pembrolizumab) combined with Padcev (enfortumab vedotin-ejfv), which has shown promising results in a broader first-line population, irrespective of cisplatin eligibility.
6. Opdivo is associated with warnings and precautions such as severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, and others.
Relevant Search Results:
- Bristol Myers Squibb press release (1): https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Approves-Opdivo--nivolumab-in-Combination-with-Cisplatin-and-Gemcitabine-for-First-Line-Treatment-of-Adult-Patients-with-Unresectable-or-Metastatic-Urothelial-Carcinoma/default.aspx
- Endpoints News (2): https://endpts.com/bristol-myers-squibb-nabs-approval-for-opdivo-combo-as-first-line-bladder-cancer-treatment/
- FiercePharma (3): https://www.fiercepharma.com/pharma/bristol-myers-overshadowed-adc-wins-fda-nod-opdivo-combo-bladder-cancer
- LinkedIn post (4): https://www.linkedin.com/posts/biospaceinc_bms-wins-fda-approval-for-opdivo-in-first-line-activity-7171909578840764416-7tkb
- BioSpace article (5): https://www.biospace.com/article/bms-wins-fda-approval-for-opdivo-in-first-line-bladder-cancer/