RAHWAY, N.J. - Merck, a leading global biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, in combination with chemotherapy, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma, irrespective of mismatch repair status. This marks the third FDA-approved indication for KEYTRUDA in endometrial carcinoma and the 40th indication for KEYTRUDA in the U.S.
The approval is supported by data from the Phase 3 NRG-GY018 trial, which showed that KEYTRUDA plus chemotherapy reduced the risk of disease progression or death by 40% in patients with mismatch repair proficient (pMMR) tumors and by 70% in patients with mismatch repair deficient (dMMR) tumors, compared to placebo with chemotherapy.
Dr. Ramez N. Eskander, the trial's principal investigator, highlighted the significance of the combination therapy, offering a new frontline therapeutic option that demonstrates a clinically meaningful progression-free survival benefit.
However, immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, affecting any organ system or tissue at any time during or after treatment. The safety profile also includes risks for fetal harm, infusion-related reactions, and complications of allogeneic hematopoietic stem cell transplantation.
The trial was sponsored by the U.S. National Cancer Institute (NCI) with funding from NCI and participation from National Clinical Trials Network groups. Merck provided funding and support through a Cooperative Research and Development Agreement (CRADA) with NCI.
Endometrial cancer is the most common gynecologic cancer in the U.S., with projected deaths expected to surpass those from ovarian cancer in 2024, emphasizing the need for new treatments.
This FDA approval was reviewed under Project Orbis, an initiative for concurrent review of oncology drugs among international partners. Health authorities in Israel, Canada, Australia, Singapore, Brazil, and the United Kingdom are also reviewing the application.
The information in this article is based on a press release statement from Merck & Co., Inc.
In other recent news, Merck & Co., Inc. has been making significant strides in the pharmaceutical industry. Wells Fargo has maintained its Equal Weight rating on the company, influenced by a survey that provided insights into the market reception of Merck's Winrevair. BMO Capital has also maintained an Outperform rating on Merck, following significant developments in its oncology pipeline and clinical trials.
Merck has announced its plans to acquire EyeBio, marking a strategic move into the ophthalmology sector. This acquisition will add EyeBio's novel late-phase candidate Restoret™ for diabetic macular edema and neovascular age-related macular degeneration to Merck's pipeline.
Furthermore, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Merck's KEYTRUDA, a potential treatment for malignant pleural mesothelioma. The target action date for this review has been set for September 25, 2024.
These are recent developments that reflect Merck's commitment to advancing science and improving patient outcomes in cancer care and other therapeutic areas. As these are recent developments, it will be interesting to follow how they unfold and impact the company's trajectory in the healthcare industry.
InvestingPro Insights
Merck's recent FDA approval of KEYTRUDA for the treatment of endometrial carcinoma has further solidified its position as a prominent player in the Pharmaceuticals industry. With a robust market capitalization of $322.98B and a significant presence in the oncology space, Merck is poised to continue its influence on the healthcare market.
The company's financial health remains strong, as evidenced by a healthy operating income margin of 28.55% over the last twelve months as of Q1 2024. Moreover, Merck's commitment to shareholders is clear with its impressive track record of maintaining dividend payments for 54 consecutive years, and the dividend yield stands at 2.39% as of mid-2024. This dedication to consistent shareholder returns is further supported by a 5.48% dividend growth in the same period.
InvestingPro Tips reveal that Merck has raised its dividend for 13 consecutive years, and net income is expected to grow this year, which could be promising news for investors looking for both growth and income. Moreover, the company's stock generally trades with low price volatility, providing a degree of stability in an investor's portfolio.
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As Merck continues to advance in the pharmaceutical industry with innovative treatments like KEYTRUDA, investors may find value in keeping a close eye on the company's financial health and market performance.
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