J&J gets its first broad Rybrevant nod

Look out, Tagrisso: Johnson & Johnson’s Rybrevant has entered the broad first-line EGFR-mutated NSCLC arena. The EGFR x cMet bispecific was approved Tuesday in combination with the oral EGFR-TKI lazertinib (now trademarked Lazcluze) – a key step towards J&J’s multiblockbuster ambitions. Rybrevant’s chances of being a big seller still look unclear, however: while the Mariposa trial, on which the decision was based, showed Rybrevant plus Lazcluze beating Tagrisso, the result was flattered by underperformance in the control arm. And AstraZeneca has moved on, getting a Tagrisso-chemo combo greenlit in first-line NSCLC, despite a lack of OS benefit. On the plus side for J&J, Lazcluze’s label looks cleaner than Tagrisso’s, which features various warnings including for QTc prolongation and cardiomyopathy. The Mariposa nod has come before a decision in second-line disease, where J&J filed first based on Mariposa-2. Here the company is focused on Rybrevant plus chemo, rather than a triplet including Lazcluze, which was also studied. But the bigger outstanding approval decision, in terms of sales potential, concerns a subcutaneous formulation of Rybrevant; last week J&J said this had been granted priority review, although the PDUFA date wasn't disclosed.

Recent and upcoming Rybrevant decisions

Source: OncologyPipeline & company releases.