Roche's Tecentriq lines up for billion-dollar market with FDA priority tag

Roche’s Tecentriq is closing in on a billion-dollar-plus lung cancer market that it can have all to itself.

On Wednesday, U.S. regulators granted the immunotherapy a priority review in previously untreated patients with extensive-stage small cell lung cancer. The move sets up Tecentriq—which regulators will evaluate alongside chemotherapy—for a speedy trip down the regulatory pathway, with the FDA expected to hand down a decision by March 18.

If Tecentriq can snag an OK, it will be the first time in 20 years that extensive-stage SCLC patients have had a front-line option that “delivers a clinically meaningful survival benefit," Sandra Horning, M.D., Roche’s chief medical officer and head of global product development, said in a statement. Tecentriq put that benefit on display in the company’s phase 3 IMpower-133 trial, which showed the therapy could extend patients’ lives by an average of 12.3 months—two months longer than solo chemo.

With that edge in mind, Baader Helvea analysts have predicted an indication could generate $1.5 billion for Roche, which won’t be fighting off its usual rivals in the small-cell arena—at least, for now. Bristol-Myers Squibb, for its part, opted to test its Opdivo-Yervoy pairing as a maintenance treatment after front-line chemo instead of as an initial treatment, and the company recently revealed that the combo had failed its phase 3 trial.

RELATED: BMS' second small-cell trial flop endangers Opdivo lung cancer approval: analyst

“It’s unclear what thought process BMS used internally in deciding not to have a clear 1L SCLC trial,” Evercore ISI analyst Umer Raffat wrote at the time.

But Roche, which has struggled to gain traction in a lung cancer market dominated by Merck’s Keytruda, doesn’t mind having some space. Outside the lung cancer arena, Tecentriq is also seeking to become the first drug in its class approved for tough-to-treat triple negative breast cancer.