Opdivo cleared for lung cancer in record time

Bristol-Myers Squibb’s Opdivo has been cleared in the US to treat lung cancer, a full three months ahead of the FDA’s review deadline.

The positive verdict by the agency gives PD-1 or checkpoint inhibitor Opdivo (nivolumab) a several-month lead over its closest rival – Merck & Co’s Keytruda (pembrolizumab) – which is scheduled to be submitted for approval in lung cancer around the middle of 2015.

Also closing in on the NSCLC indication is Roche’s MPDL3280A, whose lead indication is bladder cancer but could be submitted for lung cancer before the end of 2015, which in turn is a few months ahead of AstraZeneca’s MEDI4736.

The FDA has approved Opdivo – which is already used to treat melanoma – for metastatic squamous non-small cell lung cancer (NSCLC) that has progressed despite platinum-based chemotherapy.

Lung cancer is a much larger market than melanoma and is the leading cause of cancer death in the US, with almost 225,000 new cases a year and around 160,000 deaths.

The green light comes just two months after BMS stopped a trial of Opdivo in NSCLC early on the grounds that it achieved superior overall survival compared to standard therapy with docetaxel.

“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, director of the agency’s Office of Hematology and Oncology Products.

The company said it plans to price the drug at about $12,500 a month, or $150,000 for patients who stay on it for a year, which is line with the price of the drug for the melanoma indication.

Analysts at Goldman Sachs have predicted that peak sales of nivolumab will reach $7 billion by 2025, with the entire PD-1 inhibitor class representing a $10 billion-$15 billion market opportunity at peak, although others have predicted the class could eventually bring in as much as $25 billion-$30 billion.

The approval comes as BMS has just expanded its immuno-oncology portfolio with three new deals, taking an option on a prostate cancer vaccine from Bavarian Nordic in a $975 million deal, buying Flexus Biosciences for $1.2bn and forming an $309 million alliance with Rigel for small-molecule cancer drugs.

The frenzied deal-making reflects the fact that the long-term potential of immunotherapies is thought to lie in the use of the drugs in combination, which are expected to show even more impressive efficacy.

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