Johnson & Johnson (JNJ) just made cancer treatment a lot faster. On Wednesday, the FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), marking the first subcutaneously administered therapy for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer. If you're wondering what that means in practical terms, think about this: what used to take several hours now takes five minutes.
The new formulation is approved for all the same indications as the original intravenous version of Rybrevant, but the delivery method changes everything. Instead of sitting through hours of IV infusion, patients can now receive their treatment via a quick injection under the skin. That's not just convenient for patients—it's a massive win for healthcare systems dealing with resource constraints.
The Numbers Tell the Story
Rybrevant Faspro delivers some impressive improvements over traditional IV delivery. Administration time drops from several hours to five minutes, which is significantly faster than chemotherapy-based regimens that can take up to an hour. But speed isn't the only advantage here.
The subcutaneous version showed an approximately fivefold reduction in administration-related reactions, with only 13% of patients experiencing these issues compared to 66% in the IV group. Blood clot risks also dropped, with venous thromboembolism occurring in 11% of subcutaneous patients versus 18% for those receiving IV treatment.
The Phase 3 PALOMA-3 study backed up these findings, with Rybrevant Faspro meeting both co-primary pharmacokinetic endpoints and delivering results consistent with the original formulation. Data presented at ASCO in 2024 and published in the Journal of Clinical Oncology showed that the subcutaneous arm had longer duration of response, improved progression-free survival, and longer overall survival compared to IV delivery.
Here's where it gets really interesting: at 12 months, 65% of patients receiving subcutaneous treatment were alive, compared with just 51% treated with IV. That survival advantage was particularly notable for patients also receiving Lazcluze (lazertinib) alongside the subcutaneous formulation.
Another FDA Win for Subdural Hematomas
Johnson & Johnson scored a second FDA approval on Thursday, this time for an expanded indication of its TRUFILL n-BCA Liquid Embolic System. The device can now be used for embolization of the middle meningeal artery to treat symptomatic subacute and chronic subdural hematomas as an adjunct to surgery.
Chronic subdural hematomas typically result from minor head trauma that causes bleeding between the dura and arachnoid membranes. It's particularly common in older adults and people on anticoagulation therapy. Surgery has been the standard treatment, but recurrence rates run between 10% and 20%, which isn't great.
The TRUFILL system offers a minimally invasive endovascular approach by targeting smaller brain vessels that contribute to hematoma persistence and regrowth. Data from the MEMBRANE trial showed that TRUFILL n-BCA was superior in effectiveness compared to standard care, while also demonstrating a strong safety profile.
JNJ Price Action: Johnson & Johnson shares were down 0.70% at $208.86 at the time of publication on Thursday. The stock is approaching its 52-week high of $215.18.
