Bristol-Myers barrels toward approval with a blockbuster cancer combo

The greatest promise of a new crop of immuno-oncology treatments likely comes from using them in combination with one another, clinicians say. And Bristol-Myers Squibb ($BMY), maker of two such drugs, is looking to couple its blockbuster treatments in a package deal, rolling toward FDA approval with a tandem therapy.

The agency accepted Bristol-Myers' application for a pairing of Opdivo and Yervoy to treat melanoma, promising to hand down a final yes or no by Sept. 30. Yervoy, first approved in 2011, blocks the protein CTLA-4, which functions like an off switch for immune cells. And Opdivo, cleared earlier this year, attacks the similar PD-1, effectively unblinding the body's natural defenses by breaking down so-called immune checkpoints. In Phase III trials, a combination of the two has proven significantly better than its individual parts at shrinking tumors and extending survival, and now Bristol-Myers wants to sell them as a one-two punch.

Doctors can of course already prescribe Yervoy and Opdivo together, but they could just as easily sub the latter treatment for Keytruda, a PD-1-blocking therapy from Merck ($MRK). By chasing a tandem approval, Bristol-Myers is looking to corner the market for combo immunotherapies in melanoma, presenting oncologists with a unified front.

But, as with everything in oncology, pricing is sure to be an issue. At the weekend's annual American Society of Clinical Oncology meeting, Memorial Sloan Kettering's Leonard Saltz bemoaned the soaring cost of cancer drugs, using Bristol-Myers' combo as a case study. The data on the two treatments are "truly, truly remarkable for a disease that five years ago we thought was virtually untreatable," Saltz said, according to the Wall Street Journal. But at their current prices, a combination of Yervoy and Opdivo would cost nearly $300,000 a year for the average melanoma patient, according to Saltz, and that's just not sustainable.

Many analysts believe Bristol-Myers will discount its combo therapy once the pairing is approved, at once appeasing pharmacy benefit managers and discouraging oncologists from mixing and matching drugs from its rivals. The company has not commented on potential pricing for the combination.

For now, Merck and Bristol-Myers are the only players in the PD-1 space, but similar treatments from Roche ($RHHBY), AstraZeneca ($AZN) and Pfizer ($PFE) are slated to hit the market in the coming years.

- read the statement
- here's the WSJ story

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