Also known as: Rybrevant, RYBREVANT, Rybrevant Faspro, RYBREVANT FASPRO
Amivantamab is a bispecific monoclonal antibody anti-cancer therapy marketed as Rybrevant for EGFR-mutated non-small cell lung cancer settings. It targets EGFR and MET pathways and is used in locally advanced or metastatic NSCLC indications. The drug first received U.S. approval in 2021 with later indication expansions.
Johnson & Johnson faces new talc verdicts in Minnesota and Pennsylvania totaling over $10 million, with 67,000+ lawsuits pending. Meanwhile, the FDA approved a new monthly dosing for RYBREVANT FASPRO, and the company launched its Shockwave C2 Aero coronary catheter globally.
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
Heather Quintana Suchan said early biomarker testing and genomic profiling identified an exon 20 mutation and helped match her to Rybrevant for stage 4 lung cancer. She said the treatment is working well with minimal side effects and is urging patients to seek personalized testing early.
Johnson & Johnson raised its full-year forecast after stronger-than-expected quarterly results driven by cancer, immunology and neuroscience drugs. Sales were $24.56 billion and adjusted earnings were $2.46 per share, with Innovative Medicines sales rising 10.0% to $15.76 billion.
Johnson & Johnson reported strong Q4 2025 earnings with $2.46 adjusted EPS and $24.56 billion in sales, beating estimates. The company faces over 67,000 active talc lawsuits following recent trial losses while projecting 2026 sales of $100-101 billion and maintaining a robust pipeline with recent FDA approvals and breakthrough designations.
The FDA approved subcutaneous amivantamab for EGFR-mutated NSCLC in December 2025 based on phase 3 PALOMA-3 trial data showing noninferior efficacy with reduced infusion reactions and 5-minute administration time. The formulation decreases infusion-related reactions from 66% to 13% and improves patient convenience and quality of life. Recent MARIPOSA trial updates show amivantamab plus lazertinib extends median overall survival by at least 12 months versus osimertinib monotherapy.
The FDA has approved a monthly subcutaneous dosing schedule for Johnson & Johnson's Rybrevant Faspro for EGFR-mutated NSCLC, based on PALOMA-2 trial data showing 82-87% response rates. The approval follows the drug's initial biweekly dosing approval in December 2025 and offers reduced administration time and reactions compared to intravenous delivery.
Phase 2 trial of amivantamab in recurrent/metastatic adenoid cystic carcinoma achieved 72.2% clinical benefit rate with good tolerability. Combination therapy with pembrolizumab is being evaluated in head and neck squamous cell cancer.
The FDA has approved a new monthly dosing schedule for Johnson & Johnson's Rybrevant Faspro combined with Lazcluze for first-line treatment of advanced EGFR-mutated non-small cell lung cancer, allowing patients to transition to monthly dosing as early as week five.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07586202 |
A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC |
NOT_YET_RECRUITING | PHASE2 |
| NCT07392658 |
Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations. |
RECRUITING | PHASE2 |
| NCT07276399 |
A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer |
RECRUITING | PHASE3 |
| NCT07227025 |
A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT06750094 |
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy |
RECRUITING | PHASE3 |
| NCT06667076 |
A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) |
RECRUITING | PHASE2 |
| NCT06662786 |
A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer |
RECRUITING | PHASE3 |
| NCT06632236 |
5G-EMERALD: Amivantamab in Malignant Brain Tumours |
RECRUITING | PHASE1 |
| NCT06532032 |
A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT06507306 |
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies |
RECRUITING | PHASE1 |
