PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) announced today that the European Commission (EC) has approved the use of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). This marks the first approval in the European Union for a concurrent immunotherapy-chemotherapy combination for these patients.
The approval is based on the results from the CheckMate -901 trial, which showed that the combination of Opdivo with cisplatin and gemcitabine followed by Opdivo monotherapy led to statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone. The trial demonstrated a 22% reduction in the risk of death and a 28% reduction in the risk of disease progression or death when compared to standard chemotherapy.
Dr. Dana Walker, vice president and global program lead, gastrointestinal and genitourinary cancers at Bristol Myers Squibb, expressed gratitude to the patients, families, and researchers involved in the trial and emphasized the significance of this new treatment option for patients with difficult-to-treat cancers.
Dr. Michiel Van der Heijden, a medical oncologist and research group leader at the Netherlands Cancer Institute, highlighted the importance of the findings, suggesting that concurrent Opdivo and chemotherapy should be considered as a new standard of care for eligible patients with this type of cancer.
The safety profile of the combination was consistent with the known safety profiles of the individual components, and no new safety concerns were identified. The most common adverse reactions reported were nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, and peripheral neuropathy.
This approval extends to all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. It supports the EU's previous approval of Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. Opdivo-based options are also approved for treatment of 10 different cancer types in the EU.
Bladder cancer is the ninth most common cancer globally, with urothelial carcinoma accounting for approximately 90% of all cases. The prognosis for patients with metastatic UC is poor, with a median overall survival of approximately 12 to 14 months when treated with systemic therapy.
This article is based on a press release statement from Bristol Myers Squibb.
InvestingPro Insights
As Bristol Myers Squibb (NYSE: BMY) secures approval from the European Commission for its groundbreaking cancer treatment, investors and stakeholders may take a closer look at the company's financial health and market performance. The recent metrics from InvestingPro show a mixed picture for the pharmaceutical giant. The company's market capitalization stands at a robust $82.08 billion, reflecting a significant presence in the industry. However, the P/E ratio is currently negative at -13.5, which may raise eyebrows among investors looking for profitability indicators. On a more positive note, the adjusted P/E ratio for the last twelve months as of Q1 2024 is 12.18, suggesting a more favorable earnings perspective when one-time items are excluded.
While the company's revenue has seen a slight decrease of 0.68% over the last twelve months as of Q1 2024, the gross profit margin remains strong at 76.03%, indicating effective cost management relative to revenue. Additionally, the dividend yield of 5.93% as of mid-April 2024 is particularly attractive to income-seeking investors, especially considering that Bristol Myers Squibb has maintained dividend payments for 54 consecutive years, as per an InvestingPro Tip. This demonstrates a commitment to returning value to shareholders, which may be a comforting sign in volatile market conditions.
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