Also known as RYBREVANT.
Subcutaneous bispecific (amivantamab + hyaluronidase) approved for adults with recurrent/metastatic head and neck squamous cell carcinoma after platinum and anti‑PD‑(L)1 therapy.
Cohort 5 reported 77% confirmed ORR (14% CR) in non‑HPV HNSCC with subcutaneous amivantamab + pembrolizumab and carboplatin; median follow‑up 10.6 months; safety consistent with known profiles.
New clinical results include first-in-human data for oral RIPTAC JNJ-6143 in mCRPC, late-breaking PROTEUS Phase 3 prostate results, and expanded RYBREVANT FASPRO datasets across lung and head & neck cancers.
Final overall survival data for RYBREVANT plus chemotherapy in EGFR exon 20 insertions and tolerability updates for subcutaneous RYBREVANT FASPRO with prophylactic strategies.
OrigAMI-4 showed 42% response rate with >1/3 complete responses; FDA review shortened to ~6 months; drug targets EGFR and MET and is co-formulated with hyaluronidase.
Phase 1b/2 OrigAMI-4: subcutaneous amivantamab + hyaluronidase achieved 42% ORR (15% CR) in pretreated recurrent/metastatic HNSCC; median DOR not reached (11.8 mo FU); manageable safety.
European Commission approves subcutaneous RYBREVANT® for flexible dosing in advanced EGFR-mutated NSCLC, offering reduced clinic time and fewer reactions.
The OrigAMI-4 study shows amivantamab with immunotherapy offers durable antitumor activity in recurrent/metastatic head and neck cancer, improving outcomes over current treatments.
