The field of immuno-oncology offers significant commercial potential and has invited attention from many established health care companies. Companies like Bristol-Myers Squibb Company (BMY), AstraZeneca (AZN) and Roche (RHHBY) are eyeing the lucrative space. Immuno-oncology treatments make use of the natural capability of the patient's own immune system to eliminate cancer cells.
Bristol-Myers believes that the successful development and subsequent commercialization of its immuno-oncology treatment Opdivo (nivolumab, a PD-1 immune checkpoint inhibitor) will boost its immuno-oncology franchise. The candidate is already under review in the U.S. and EU for the advanced melanoma indication.
Earlier this week, Bristol-Myers announced that Opdivo is under review in the EU for the non-small cell lung cancer indication as well. Bristol-Myers stated in its press release that following the acceptance of the Marketing Authorisation Application by the European Medicines Agency, Opdivo becomes the first drug in its category to be under review in the EU for lung cancer.
Bristol-Myers submitted the marketing application for Opdivo on the basis of encouraging data from a phase II study (063) in the third-line pre-treated squamous cell NSCLC indication. Moreover, the biopharmaceutical major has initiated a rolling submission in the U.S. for the above indication based on results from the 063 study. Bristol-Myers expects to complete the rolling submission by Dec 31, 2014.
We remind investors that in Sep 2014, Merck & Co.'s (MRK) Keytruda became the first anti PD-1 drug to gain approval in the U.S. However, Bristol-Myers filed a lawsuit against Merck immediately thereafter accusing it of patent infringement (read more: Bristol-Myers Sues Merck of Patent Infringement on Keytruda).
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