Eli Lilly has new data that could help expand Cyramza’s lung cancer footprint, but it’ll face a tough marketing battle if new approvals follow.
Tuesday, the Indianapolis drugmaker said a phase 3 trial had showed the drug, in tandem with Roche’s Tarceva, could beat out a combination of Tarceva and placebo at staving off progression of EGFR-mutated lung cancer in patients new to treatment.
The company is keeping the details of the win under wraps, but it intends to begin filing for approvals around the world in the middle of this year, it said.
But even if it can snag them, entering the EGFR field will be no walk in the park. Plenty of rivals are already duking it out in that arena—not the least of which is AstraZeneca’s Tagrisso, which grabbed its first-line nod last April and rocketed to $1.86 billion in 2018 sales.
But the way Lilly sees it, there’s still room for new therapies. “Despite recent treatment advances in metastatic EGFR-mutated non-small cell lung cancer, prognosis remains poor and there is an ongoing need for additional first-line treatment options to help patients with this deadly disease,” Maura Dickler, M.D., Lilly Oncology’s VP of late phase development, said in a statement.
Cyramza’s history has been dotted with both successes and failures in the clinic as Lilly has sought to expand the drug’s use. Lately, things have been on the up-and-up, with last April’s biomarker win in liver cancer and a phase 3 bladder cancer victory in 2017. Before that, though, trials of the med in liver cancer and breast cancer came up short.
Meanwhile, Cyramza’s current FDA indications—in stomach cancer, gastroesophageal junction adenocarcinoma, previously treated non-small cell lung cancer and colorectal cancer—helped it rack up $821.4 million in 2018 sales, though the vast majority of those sales came outside the U.S.