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Bristol-Myers Squibb Withdraws Regulatory Application For Lung Cancer Combo Drug

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Bristol-Myers Squibb Withdraws Regulatory Application For Lung Cancer Combo Drug
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Bristol-Myers Squibb Co (NYSE: BMY) shares are sliding Thursday despite the company reporting forecast-beating Q4 results. The negative sentiment could be traced back to a regulatory update the company issued for its cancer drug combo that is being evaluated for lung cancer.

What Happened

Bristol-Myers Squibb said following its discussions with the FDA, it has decided to voluntarily withdraw its sBLA for the Opdivo and low-dose Yervoy immunotherapy combo that's being evaluated as a first-line treatment for advanced non-small cell lung cancer in patients with tumor mutation burden (TMB) equal to or more than 10 mutations/megabase.

The review period for the combo was extended by three months to May 20, 2019, following the submission of an exploratory overall survival analysis for the TMB subgroup.

With the FDA requiring further evidence on the relationship between TMB and PD-L1, the company deemed final data from the CHECKMATE-227, Part 1a study is necessary. Since the data, due in the first half of 2019, is unlikely to be available within the review cycle of the current application, the company decided to withdraw the application.

Meanwhile, the company reported Q4 non-GAAP EPS of 94 cents, higher than the 68 cents reported a year-ago and the 85-cent consensus estimate. Revenues rose 10 percent to $5.97 billion, in line with the $5.99 billion consensus estimate.

Why It's Important

Lung cancer is the most commonly occurring cancer in men and the third most commonly occurring cancer in women, according to statistics from the American Institute for Cancer Research. The setback now gives rival Merck & Co., Inc. (NYSE: MRK), with its Keytruda, a further foothold in the lucrative market.

Bristol-Myers Squibb's recently announced the acquisition of Celgene Corporation (NASDAQ: CELG), which according to some analysts, was due to a lack of confidence in Opdivo's ability to make inroads into the lung cancer drug market, the Reuters reported.

Bristol-Myers Squibb shares were down 2.8 percent at $48.56 Thursday morning.

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