Among the scrum of drugmakers racing forward with a new class of cancer treatments, Bristol-Myers Squibb ($BMY) was the first to win a global regulatory nod and is now first in line for approval in lung cancer, a particularly lucrative indication for the group of promising oncology drugs.
The company has completed a European application to get its drug, nivolumab, approved to treat non-small cell lung cancer (NSCLC). The European Medicines Agency has accepted its filing, Bristol-Myers said, promising an accelerated assessment of the treatment. The speedy application is based on Phase II data in which nivolumab met its goal of improving objective response rate in 100 patients with squamous cell NSCLC, the company said.
The move makes Bristol-Myers the first among rivals including Merck ($MRK), Roche ($RHHBY) and AstraZeneca ($AZN) to complete an NSCLC application for a new generation of cancer treatments that promise to bring in billions in sales. Each of the companies is developing a treatment designed to galvanize an immune system attack on tumors by blocking a pathway called PD-1, which, left unchecked, allows cancerous cells to pass undetected.
The industry's first PD-1 target was skin cancer. In July, Bristol-Myers and partner Ono Pharmaceutical notched a milestone first approval by winning Japanese OK to use nivolumab, which will sell as Opdivo, to treat melanoma. And, earlier this month, Merck made the first U.S. landfall by winning FDA approval for its own pembrolizumab, marketed as Keytruda, in the same indication. Bristol-Myers expects to earn the same badge for nivolumab by March.
But lung cancer, the leading cause of global cancer deaths, is the big target for all of the PD-1 contenders, and Bristol-Myers leads the way in the space. In addition to its EU application, the company is in the midst of a rolling submission process with the FDA, planning to wrap up nivolumab's NSCLC filing by year's end.
Like its competitors, Bristol-Myers has mounted an expansive R&D program for its PD-1 candidate, running more than 35 trials in total that test nivolumab alone or as part of a cocktail in renal cell carcinoma, head and neck cancer, glioblastoma, non-Hodgkin lymphoma and other cancers.
At stake is the largest share of a PD-1 market projected to peak as high as $35 billion a year, assuming each entrant succeeds with its plans to string together regulatory approvals for a wide range of malignancies. Analysts expect Bristol-Myers to lead the pack, with peak sales estimated at around $6 billion for nivolumab.
- read the release
Special Report: The top 15 late-stage blockbusters in the pipeline - Nivolumab, Bristol-Myers Squibb