Roche's atezo gets FDA fast track, BMS, Merck showdown coming

Roche's headquarters
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Watch out, Keytruda and Opdivo: Roche snagged another FDA priority review for its cancer immunotherapy atezolizumab, this time in lung cancer. The Swiss drugmaker has big plans for the therapy, including an all-out push to gain share from the drugs that beat it to market.

Fortunately for Bristol-Myers Squibb and Merck & Co., Roche's bid for share won't be easy. Those companies launched first, and they're taking advantage of that. Bristol-Myers is already mounting a major direct-to-consumer ad push on Opdivo, and Merck is set to do the same.

Roche isn't cavalier about the challenge: Executives have been building their case for the med with a raft of clinical studies, and they've emphasized the ways atezolizumab is different from the other two.

One differentiating factor--compared with Opdivo, at least--is diagnostic testing. Atezo is up for approval as a treatment for patients who test positive for the PD-L1 biomarker. It targets the drug to patients most likely to respond.

So does Merck's Keytruda, and there's trial data to show it, with Keytruda matching Opdivo at prolonging patients' lives, specifically in the PD-L1 group. But the test adds an additional step on the way to a prescription.

Here's where beating a rival to market becomes less of an advantage. Merck is reportedly having trouble getting doctors on board with those pretherapy diagnostics. It's working to make PD-L1 testing standard procedure in lung cancer, and that takes time. But doctors' current reluctance gives Opdivo an edge, because busy doctors might just forgo the test and pick Opdivo instead.

The Swiss drugmaker has its own diagnostics group, and it has made other diagnostic-targeted drugs--Herceptin for HER2-positive breast cancer, obviously--into some of the biggest-selling meds in the world. It can turn its sales and marketing force, adept at the diagnostic-drug pairing, onto PD-L1 testing. As FierceBiotech pointed out last year, Roche enjoys nothing more than defining patient groups most likely to respond to one of its drugs, and in this case that business practice will be key to carving out a significant share.

That, in turn, might just help Merck get over the diagnostics hump with Keytruda. If doctors get in the habit of running the PD-L1 test, then why not for Keytruda as well as atezolizumab? Then again, Roche could benefit from Merck's awareness efforts, too.

In the end, analysts figure atezolizumab to be a $3 billion drug. They peg Opdivo at more than twice that, at $8.4 billion, according to EvaluatePharma. Keytruda, for its part, is expected to rake in $4.5 billion.

- see the release from Roche