Johnson & Johnson Secures FDA Approval for RYBREVANT FASPRO, Significantly Cutting NSCLC Treatment Time
J&J's RYBREVANT FASPRO™ Approved by FDA for EGFR-Mutated NSCLC
Johnson & Johnson (JNJ) announced a significant regulatory milestone on December 17, 2025, with the U.S. Food and Drug Administration (FDA) approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj). This new formulation is the first and only subcutaneously (SC) administered therapy approved for patients diagnosed with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
The approval is material for patients and healthcare providers primarily because it drastically improves the efficiency of drug delivery. RYBREVANT FASPRO™ reduces the administration time from hours to mere minutes, while also significantly decreasing the incidence of administration-related reactions compared to the intravenous (IV) formulation, RYBREVANT® (amivantamab-vmjw).
Simplifying First-Line Combination Regimen
RYBREVANT FASPRO™ is approved across all existing indications of RYBREVANT®. Its most notable application is in a first-line combination regimen when paired with LAZCLUZE® (lazertinib). This combination offers a chemotherapy-free treatment option for EGFR-mutated NSCLC.
The approval is underpinned by robust clinical data from the Phase 3 MARIPOSA study, which demonstrated an unmatched overall survival benefit for the combination regimen. This benefit is projected to exceed four years, positioning the treatment as a potential new standard of care in this patient population.
RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions.
Broader Oncology Portfolio Momentum
The FDA approval of RYBREVANT FASPRO™ highlights J&J's ongoing commitment to expanding and improving its oncology portfolio through innovative delivery methods. Subcutaneous formulations, like the one for amivantamab, are increasingly becoming a focus area for pharmaceutical companies due to their potential to enhance patient convenience and streamline clinical workflows.
This development follows other recent positive news for J&J's oncology pipeline, including the expansion of its prostate cancer treatment options with the FDA approval for Akeega. Furthermore, the company is advancing its multiple myeloma treatments, with unprecedented results from the Phase 3 MajesTEC-3 study supporting TECVAYLI® (teclistamab) plus DARZALEX FASPRO® (daratumumab) subcutaneous formulation as a potential standard of care as early as the second line for patients with relapsed/refractory multiple myeloma.
Market and Financial Context
The approval comes as J&J prepares for its fourth-quarter earnings call scheduled for January 21, 2026. Successes in key therapeutic areas like NSCLC and multiple myeloma are critical for maintaining growth in J&J's pharmaceutical segment, particularly as the company navigates patent expirations and competitive pressures.
The shift to a subcutaneous delivery method for a high-value oncology drug like RYBREVANT is strategically important. It not only improves the patient experience but also helps secure market share by offering a differentiated product that is easier to administer in various clinical settings, potentially reducing healthcare costs associated with prolonged IV infusions.
- Drug: RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)
- Indication: EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
- Key Benefit: Reduces administration time from hours to minutes
- Clinical Basis: Phase 3 MARIPOSA data showing unmatched overall survival benefit
- Combination Regimen: Used with LAZCLUZE® (lazertinib)
