'Breakthrough' tag puts Roche's Alecensa in line for ALK-market battle with Pfizer

roche building

Last month, Novartis put up data supporting a first-line nod for its med for ALK+ non-small cell lung cancer, Zykadia. But this week? It’s Roche’s contender that’s zooming ahead.

Monday, Roche’s Alecensa picked up a breakthrough therapy designation from the FDA in patients who haven’t yet been treated with ALK-inhibitor drugs. That puts the drug on track for a speedy trip down toward approval. It’s the second breakthrough nod for Alecensa, which launched last December as a treatment for patients who'd failed on Pfizer’s targeted med Xalkori.

This new use in previously untreated patients would help Alecensa take on its Pfizer rival, which racked up $488 million in sales last year with the first-line setting all to itself. Roche would like to snag a piece of the market, to build on Alecensa's current sales of $74 million through the first half of this year.

Roche isn’t the only one eyeing a piece of Xalkori’s market, though. Fellow Swiss giant Novartis' player in the mix, Zykadia, recently topped standard chemo at improving progression-free survival in previously untreated patients.

In addition to the breakthrough tag, though, Roche may have a leg up on its crosstown rival when it comes to trial design. "It's better to design something against the standard of care," Bank Vontobel analyst Stefan Schneider has told Reuters, criticizing the Novartis trial setup that pitted Zykadia against chemo. "Taken from the current data, we assume that Alecensa will be superior to Zykadia from an efficacy and safety perspective in the first line ALK+ non-small cell lung cancer."

Alecensa is already beating out Zykadia in the sales race, too; Novartis’ entrant generated $48 million in the first half of 2016.

- read the release

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