Wired News – FDA Accepts Bristol-Myers Squibb’s Application for Opdivo Plus Low-Dose Yervoy for First-Line Non-Small Cell Lung Cancer Treatment

LONDON, UK / ACCESSWIRE / June 26, 2018 / If you want access to our free research report on Bristol-Myers Squibb Co. (NYSE: BMY), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=BMY as the Company’s latest news hit the wire. On June 22, 2018, the Company announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). The target FDA action date is February 20, 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, Bristol-Myers Squibb 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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TMB is a quantitative biomarker that reflects the total number of mutations carried by tumor cells. Tumor cells with high TMB have higher levels of neo-antigens, which are thought to help the immune system recognize tumors and incite an increase in cancer-fighting T cells and an anti-tumor response.

sBLA was Based on Results from Part 1 of CheckMate-227

The application was based on results from Part 1 of CheckMate-227, the first and only global Phase-3 study to evaluate an I-O/I-O regimen versus chemotherapy in a population of first-line NSCLC patients with TMB ≥10 mut/Mb, across squamous and non-squamous tumor histologies and the PD-L1 expression spectrum. The data was presented at the American Association for Cancer Research Annual Meeting 2018 and published in The New England Journal of Medicine. CheckMate-227 is an ongoing, multi-part, open-label global Phase-3 trial evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced NSCLC across squamous and non-squamous tumor histologies.

China National Drug Administration Approved Country’s First Immuno-Oncology Agent, Opdivo, for Previously Treated NSCLC

On June 15, 2018, the China National Drug Administration (CNDA) approved Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic NSCLC after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations. This is China’s first and only PD-1 inhibitor and is the only I-O agent to demonstrate a survival benefit compared to chemotherapy, based on data from the pivotal Phase-3 CheckMate-078 trial, in which 90% of the patients enrolled were Chinese.

About Non-Small Cell Lung Cancer (NSCLC)

NSCLC is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitive to chemotherapy compared to small cell carcinoma. When possible, they are primarily treated by surgical resection with curative intent, although chemotherapy is increasingly being used both pre-operatively and post-operatively.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union, and Japan.

About Bristol-Myers Squibb Co.

Headquartered in New York City, New York, Bristol-Myers Squibb is a global biopharmaceutical Company focused on discovering, developing, and delivering innovative medicines for patients with serious diseases.

Stock Performance Snapshot

June 25, 2018 – At Monday’s closing bell, Bristol-Myers Squibb’s stock was slightly down 0.85%, ending the trading session at $54.67.

Volume traded for the day: 6.02 million shares.

Stock performance in the last month – up 3.76%

After yesterday’s close, Bristol-Myers Squibb’s market cap was at $89.28 billion.

Price to Earnings (P/E) ratio was at 23.54.

The stock has a dividend yield of 2.93%.

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

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