J&J’s Rybrevant May Find Limited Uptake Outside Academic Centers

Johnson & Johnson is expected to aggressively promote Rybrevant (amivantamab-vmjw) following the US Food and Drug Administration’s rapid approval of the drug for a rare subset of non-small cell lung cancer (NSCLC). While Rybrevant may also have a place among NSCLC patients relapsing on AstraZeneca PLC’s Tagrisso (osimertinib), its safety and tolerability profile may place limitations on its uptake, potentially creating an opening for a competing drug in earlier development by Cullinan Oncology, Inc..

The FDA granted accelerated approval of Rybrevant on 21 May for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, a subset of the disease whose patients have a worse prognosis than those with the more common EGFR mutations. (Also see "Keeping Track: J&J’s Targeted Oncologic Rybrevant, Apellis’ C3 Inhibitor Empaveli Approved; New Filings From Takeda, Lilly" - Pink Sheet, 22 May, 2021.) The approval came five months after the company’s December 2020 biologics license application filing