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Bristol-Myers Gets Priority Review for Opdivo Label Expansion

Bristol-Myers Squibb Company BMY announced that that the FDA has granted priority review to the supplemental Biologics License Application (sBLA) for the label expansion of Opdivo.

The company is looking to get the drug approved for treating patients with melanoma, who are at high risk of disease recurrence following complete surgical resection. However, the drug is already approved for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Generally, Priority Review designation from the FDA is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. The FDA also previously granted Breakthrough Therapy Designation for this application which is the seventh indication for which Opdivo has received this designation.

The supplemental Biologics License Application is based on data from the ongoing phase III CheckMate -238 study. Bristol Myers announced encouraging results from CheckMate-238 study, on Opdivo.

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CheckMate 238 is a randomized double-blind study of Opdivo versus Yervoy in patients, who have undergone complete resection of stage IIIb/c or stage IV melanoma. Results from the study showed that Opdivo 3 mg/kg led to a significant improvement in recurrence-free survival (RFS) compared to Yervoy 10 mg/kg in patients with stage IIIb/c or stage IV melanoma following complete surgical resection. The results from the planned interim analysis showed that Opdivo met its primary endpoint, with a statistically significant improvement of 35% in RFS compared to Yervoy. In July 2017, the company reported positive results from the same study.

So far this year, Bristol-Myers’ stock has rallied 8.9% compared with the industry’s 18.2% gain.

 

In fact, Opdivo became the first PD-1 immune checkpoint inhibitor to gain regulatory approval anywhere in the world in July 2014. Notably, the drug became the first PD-1 inhibitor to be approved for a hematological malignancy — classic Hodgkin lymphoma — in both the United States (May 2016) and the EU (November 2016).

In November 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Opdivo continues to be launched globally on approvals and label expansions.  It also received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer. In fact, the Opdivo+Yervoy regimen is approved in multiple markets for the treatment of melanoma.

The drug has been performing impressively due to demand resulting from the rapid commercial acceptance for several indications. Opdivo generated revenues of $1.19 billion in the second quarter of 2017, up 42% from the year-ago period.

Meanwhile, the FDA has put a partial clinical hold on three clinical trials, CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142. These trials are investigating Opdivo-based combinations in patients with relapsed or refractory multiple myeloma. Also, concerns from AstraZeneca’s AZN failed study on lung cancer drug, Imfinzi, loom large on the company’s CheckMate 227 study on Opdivo.

Currently, Opdivo is facing competitive challenges in the United States. With the FDA approving Merck & Co.’s MRK Keytruda for the first-line treatment of metastatic nonsquamous NSCLC, Bristol-Myers is expected to suffer further loss of market share.

Bristol-Myers Squibb Company Price

 

Bristol-Myers Squibb Company Price | Bristol-Myers Squibb Company Quote

Zacks Rank & Stocks to Consider

Bristol-Myers carries a Zacks Rank #3 (Hold). Another better-ranked stocks in health care sector includes Novo Nordisk A/S NVO holding a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novo Nordisk’s earnings per share estimates have moved up $2.37 to $2.38 for 2017 and from $2.51 to $2.53 for 2018. The company pulled off positive earnings surprises in three of the trailing four quarters, with an average beat of 3.63%. The share price of the company has increased 37.6% year to date.

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Astrazeneca PLC (AZN) : Free Stock Analysis Report
 
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