Wired News – Merck Announces FDA Acceptance of Supplemental Biologics License Application for KEYTRUDA® as Adjuvant Therapy in Advanced Melanoma

LONDON, UK / ACCESSWIRE / June 27, 2018 / If you want access to our free research report on Merck & Co., Inc. (NYSE: MRK), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=MRK as the Company’s latest news hit the wire. On June 25, 2018, the Company announced that the US Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for KEYTRUDA®, which is its anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The FDA has granted a Prescription Drug User Fee Act (PDUFA), or target action date of February 16, 2019. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Merck most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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sBLA is based on Pivotal Phase-3 EORTC1325/KEYNOTE-054 Trial

This sBLA is based on a significant benefit in recurrence-free survival demonstrated by KEYTRUDA® in the pivotal Phase-3 EORTC1325/KEYNOTE-054 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). These data were presented for the first time at the American Association for Cancer Research (AACR) Annual Meeting 2018 and published in The New England Journal of Medicine.

FDA Approved KEYTRUDA® for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma

On June 13, 2018, the FDA approved KEYTRUDA® for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. This indication was approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. A continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

About Melanoma

Melanoma, also known as malignant melanoma, is a type of cancer that develops from the pigment-containing cells known as melanocytes. Melanomas typically occur in the skin, but may rarely occur in the mouth, intestines, or eye. Sometimes they develop from a mole with concerning changes, including an increase in size, irregular edges, change in color, itchiness, or skin breakdown. The primary cause of melanoma is ultraviolet light (UV) exposure in those with low levels of skin pigment.

About KEYTRUDA® (pembrolizumab)

KEYTRUDA® is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program, which currently involves more than 750 trials studying KEYTRUDA® across a wide variety of cancers and treatment settings. The KEYTRUDA® clinical program seeks to understand the role of KEYTRUDA® across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA®.

About Merck & Co., Inc.

Merck, known as MSD outside of the United States and Canada, is a leading global biopharmaceutical organization that has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Headquartered in Kenilworth, New Jersey, the Company, through its prescription medicines, vaccines, biologic therapies, and animal health products, works with customers and operate in more than 140 countries.

Stock Performance Snapshot

June 26, 2018 – At Tuesday’s closing bell, Merck’s stock marginally dropped 0.59%, ending the trading session at $60.72.

Volume traded for the day: 10.33 million shares.

Stock performance in the last month – up 2.76%; previous three-month period – up 12.97%; past six-month period – up 7.74%; and year-to-date – up 7.91%

After yesterday’s close, Merck’s market cap was at $163.64 billion.

Price to Earnings (P/E) ratio was at 39.66.

The stock has a dividend yield of 3.16%.

The stock is part of the Healthcare sector, categorized under the Drug Manufacturers – Major industry.

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