Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has accepted and granted a priority review designation to the supplemental Biologics License Application (sBLA) for the label expansion of Opdivo (nivolumab) to treat patients with small cell lung cancer (“SCLC”) whose disease has progressed after two or more prior lines of therapy. The FDA set an action date of Aug 16, 2018.
The submission was based on safety and efficacy data from the SCLC cohort of the phase I/II CheckMate-032 trial evaluating Opdivo monotherapy or Opdivo plus Yervoy (ipilimumab) in advanced or metastatic solid tumors, including SCLC. The primary goal was to ascertain the objective response rate as assessed by a blinded independent central review. Secondary objectives included safety, overall survival, progression-free survival and duration of response.
Shares of the company have declined 0.5% over a year, underperforming the industry’s gain of 11.2%.
We note that, Opdivo, became the first PD-1 immune checkpoint inhibitor to gain regulatory approval in July 2014. It is currently approved in several countries including the United States, the EU and Japan for several cancer indications. Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy — classical Hodgkin lymphoma in both the United States (May 2016) and the EU (November 2016).
In November 2016, Opdivo gained 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. The drug has been performing impressively due to demand resulting from the rapid commercial acceptance for several indications including melanoma, renal cell carcinoma, and second-line NSCLC. The FDA also approved Opdivo for intravenous use for patients with hepatocellular carcinoma (“HCC”) who have been previously treated with Nexavar and Opdivo has rapidly penetrated the second line HCC market.
Label expansion into additional indications would give the product access to a higher patient population and increase the commercial potential of the drug significantly.
However, Opdivo faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.
Zacks Rank & Another Stock to Consider
Bristol-Myers carries a Zacks Rank #3 (Hold).
Another top-ranked stocks from the same space worth considering is Ligand Pharmaceuticals (LGND - Free Report) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have moved up $3.78 to $4.40 from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 62.1% over a year.
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