Drug file · From the Watchtower
Amivantamab: the briefings and the record
Every Prognyx briefing on amivantamab, newest first, and the dated events drawn from the sources those briefings cite. Rebuilt with each new briefing.
- Also known as
- Rybrevant, RYBREVANT FASPRO
- Target, as briefed
- EGFR x MET bispecific antibody
- Companies named
- Johnson & Johnson, Janssen Biotech
- Prognyx coverage
- 2 briefings, 29 October 2026 to 6 November 2026
Prognyx briefings on amivantamab
- recurrent or metastatic head and neck squamous cell carcinoma (post-platinum)Rybrevant Faspro wins accelerated FDA approval in second-line head and neck cancer
Accelerated approval covers patients whose disease progressed after platinum chemotherapy and a PD-(L)1 inhibitor, on a 42% response rate (95% CI 32-52%) in 102 patients.
- first-line advanced head and neck cancerJ&J's RYBREVANT FASPRO posts 77% response rate in first-line head and neck cancer
J&J's subcutaneous EGFR/MET regimen showed a confirmed 77% overall response rate in previously untreated advanced head and neck cancer, supporting an ongoing Phase 3 study.
Sourced timeline
Readouts, regulatory actions, filings, trial starts and deals that the Prognyx engine extracted from the documents cited in these briefings, newest first. Each links to its source and to the briefing that cited it. Press coverage is left out, and so is any event dated on its own briefing's day: the briefing above is the record for that day. A month without a day is a date the source gave only to the month.
- ReadoutOrigAMI-4 shows 42% ORR in 2L recurrent/metastatic HNSCCPR Newswire (J&J) · cited in Rybrevant Faspro wins accelerated FDA approval in second-line h…
- Regulatory actionFDA grants accelerated approval for Rybrevant Faspro in 2L recurrent/metastatic HNSCCFDA · cited in Rybrevant Faspro wins accelerated FDA approval in second-line h…
- ReadoutRybrevant Faspro combo shows 77% ORR in 1L advanced head and neck cancerJ&J press release · cited in Rybrevant Faspro wins accelerated FDA approval in second-line h…
Registered trials on file
ClinicalTrials.gov records that the cited sources tie to amivantamab, each opening on the registry.
- NCT07586202 Neoadjuvant amivantamab with lazertinib or chemotherapy
- NCT05498428 Amivantamab in advanced or metastatic solid tumors
- NCT04538664 Amivantamab and carboplatin-pemetrexed versus carboplatin-pemetrexed
- NCT02609776 Amivantamab in advanced NSCLC
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Prognyx briefings are built from public information and reflect Prognyx's analysis. They are not investment advice and do not promote any product or off-label use. Event titles are written by the Prognyx engine from the linked source; the source is the record.