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EMA reviews Bristol Myers Squibb's cancer drug combo application

EditorBrando Bricchi
Published 05/06/2024, 03:11 PM
© Reuters.
BMY
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PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) has reached a significant milestone in the potential expansion of treatment options for colorectal cancer patients. The European Medicines Agency (EMA) has validated the company's application for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with a specific type of metastatic colorectal cancer.

This validation marks the beginning of the EMA's centralized review process. The application is based on the CheckMate -8HW study results, which showed a statistically significant and clinically meaningful improvement in progression-free survival for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) when treated with the Opdivo plus Yervoy combination compared to chemotherapy.

Dana Walker, M.D., vice president at Bristol Myers Squibb, emphasized the need for more treatment options for this patient group, who typically do not respond well to conventional chemotherapy. The combination therapy's safety profile was consistent with previous data, and no new safety signals were identified.

The CheckMate -8HW study is ongoing to assess additional endpoints, including overall survival. Colorectal cancer is the third most commonly diagnosed cancer worldwide, and patients with MSI-H/dMMR mCRC have historically had a poor prognosis.

The company expressed gratitude to the patients and investigators involved in the CheckMate -8HW clinical trial and reaffirmed its commitment to transforming patients' lives through science. This application represents a step forward in the potential availability of new therapy options for patients across Europe.

This news is based on a press release statement and does not endorse the claims of Bristol Myers Squibb. The information is presented to provide a balanced view and to report on the current status of the EMA's review process for this drug combination.

InvestingPro Insights

As Bristol Myers Squibb (NYSE: BMY) continues to innovate in the healthcare space, investors and industry watchers are keeping a close eye on the company's financial health and market performance. According to recent data from InvestingPro, Bristol Myers Squibb has a market capitalization of $89.17 billion, reflecting its significant presence in the pharmaceutical industry. Despite facing some challenges, the company's commitment to research and development could be seen in its potential expansion of treatment options for colorectal cancer patients.

An important InvestingPro Tip to consider is that management has been aggressively buying back shares, which could indicate their confidence in the company's future performance. Additionally, the stock's current Relative Strength Index (RSI) suggests it is in oversold territory, potentially presenting a buying opportunity for investors who believe in the long-term prospects of the company.

From a financial standpoint, Bristol Myers Squibb's P/E ratio stands at -14.65, reflecting a challenging period. However, on an adjusted basis for the last twelve months as of Q1 2024, the P/E ratio improves to 13.23, indicating a more favorable earnings perspective. Moreover, the company's dividend yield as of April 2024 is 5.46%, rewarding shareholders with a significant return on their investment.

For readers interested in gaining deeper insights and additional InvestingPro Tips for Bristol Myers Squibb, including the latest earnings revisions and valuation implications, visit https://www.investing.com/pro/BMY. There are 11 more tips available on InvestingPro, offering a comprehensive analysis of the company's performance and outlook. To make the most of these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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