FDA approves J&J's Rybrevant Faspro for head, neck cancer

J&J says this hard-to-treat cancer has had no new treatment option in a decade. The FDA's Nov. 5 accelerated approval of Rybrevant Faspro is aimed at exactly these patients. In the company's trial, 42% of patients responded to the drug. Older treatments worked for roughly 20%.

Rybrevant isn't new. J&J already sells it for lung cancer, paired with another drug. What's new is proving it also works alone, as a single shot, for a completely different cancer. The drug blocks two proteins, EGFR and MET, that head and neck tumors often rely on to grow. Blocking both at once is why doctors think it worked where older drugs stalled. The approval itself comes with a condition. J&J has to run a follow-up trial. It needs to confirm patients actually live longer, not just that their tumors shrank.

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Will the follow-up trial hold up? That's the real test. Drugs approved on tumor shrinkage alone sometimes fail to show a survival benefit later. When that happens, regulators can pull them from the market. For now, doctors treating this cancer get a real new option. Before Nov. 5, roughly one in five patients responded to anything available. Patients and oncologists will watch whether that holds once more people use the drug outside a trial.