Bristol-Myers Squibb Company Moving Ahead With FDA Approvals

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The pharma giant has been working on multiple aspects of drug approvals in order to keep the revenue generation

Bristol-Myers Squibb Company (NYSE:BMY) is reportedly working on the label expansion of its blockbuster molecule, Opdivo. The Food and Drug Administration (FDA) has given it a green single for the molecule’s usage among patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN); however, the approval has only been granted for patients who were not cured despite platinum-based therapy.

Opdivo has achieved the safety as well as efficacy parameters along with the enhancement in the overall survival (OS) for aforementioned patients. The OS level achievement is the golden standard in the oncology clinical trials.

The achievement marks molecule’s edge over its competitor drugs such as Merck’s Keytruda and Roche’s Tecentriq. It now has a clear chance to invade an open market and become the market leader. In addition to efforts for Opdivo’s label expansion, the drug giant is reportedly working to receive approval for bladder cancer treatment. 

The SCCHN is one of the fatal categories, which has extremely high potential of recurrence with a five-year survival rate of less than 38%. The drugmaker is said to be working on multiple oncological segments including immuno-oncology and their management through medicines despite surgery, radiation, and other factors. 

The molecule has already received approval for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. In combination with Yervoy, the regulatory body approved it for the management and treatment of unresectable or metastatic melanoma. Additionally, FDA has given approval for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) and advanced renal cell carcinoma (RCC) with previous anti-angiogenic therapy.

In the US, approximately 64,000 new cases in relation to the head and neck cancer are expected to be diagnosed including 13,000 deaths from them. In addition to working on the label expansion, the drug giant is putting in efforts on multiple agreements with companies such as Nitto Denko Corp. Following the deal, Bristol-Myers will receive global rights to develop and market Nitto’s investigational siRNA molecule indicated for the treatment of lung fibrosis as well as other organ fibrosis.

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