Roche snags first-in-class FDA nod for lymphoma drug Polivy

Roche has a trio of lucrative cancer blockbusters coming under a growing biosimilar attack, but now the company has scored an FDA nod for its latest cancer launch—and it's a first-in-class drug for patients who now have few options.

The FDA on Monday approved Roche’s Polivy, formerly known as polatuzumab vedotin, in combo with Rituxan and the chemotherapy bendamustine to treat diffuse large B-cell lymphoma patients who've failed on at least two prior treatments. The accelerated approval could be contingent on results from a confirmatory trial. Polivy will cost about $90,000 per course, a spokeswoman said via email.

And it could be a blockbuster launch, if Roche is able to win enough market share. In a note to clients back in December, Jefferies analysts wrote that the drug could pull in $1 billion at peak if it garners 50% of the market in r/r DLBCL in the U.S. and Europe, and 25% of the first-line market. A phase 3 trial in first-line DLBCL is set to wrap up at the end of this year. 

Former Roche Pharmaceuticals CEO Daniel O’Day—who now heads up Gilead Sciences—previously said he sees the drug “shifting the standard of care” in the disease, similar to the way Roche's Gazyva has in chronic lymphocytic leukemia and indolent NHL.

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Polivy won its green light on the back of phase 1b/2 results showing the combo outperformed the bendamustine and Rituxan pairing, which Roche called a “commonly used regimen" for the patient group. In the trial, 40% of patients on the Polivy combo achieved a complete response, compared with 18% on bendamustine and Rituxan.

And at the end of the treatment course, 45% of patients on the Polivy combo achieved an objective response, compared with 18% in the bendamustine and Rituxan group. 

The approval “will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease," Sandra Horning, chief medical officer of Roche's Genentech unit, said in a release. Even considering advances against the disease, Horning said “treatment options are very limited when the disease is refractory to or recurrent after multiple regimens.” 

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The approval comes as Roche’s Rituxan, Avastin and Herceptin face growing biosimilar threats in the U.S. and elsewhere. Last year, the drugs together generated more than $10 billion in U.S. sales, but Roche is expecting all three to face biosimilars in the U.S. market by year's end.

Roche isn’t taking the assault sitting down, though. The company has rolled out several new drugs, including Ocrevus, a multiple sclerosis med that hit blockbuster sales within its first year on the market. It followed that quick launch with Hemlibra, a hemophilia treatment that itself hit the ground running. 

Previously, the FDA granted the Polivy combo a priority review and a breakthrough therapy designation.