On Wednesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson (NYSE:JNJ) Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Rybrevant Faspro is approved for all indications for which Rybrevant is approved.
Compared to intravenous (IV) delivery, Rybrevant Faspro offers significantly higher patient convenience and lower burden on healthcare resources:
- Reducing administration time from several hours to five minutes (significantly less administration time than chemotherapy-based regimens, which could take up to an hour).
- Demonstrating an approximately fivefold reduction in administration-related reactions (ARRs) (13% in SC vs 66% in IV arm).
- Reducing venous thromboembolism (VTE) incidence (11% in SC vs 18% in IV arm).
Based on the results from the Phase 3 PALOMA-3 study, Rybrevant Faspro delivered consistent results to Rybrevant, meeting both co-primary pharmacokinetic (PK) endpoints.
Data presented at ASCO in 2024 and published in the Journal of Clinical Oncology also found that the SC arm showed longer duration of response (DoR), improved progression-free survival (PFS), and longer overall survival (OS) compared to the IV arm.
Median OS was notably higher for patients treated in the SC arm with Lazcluze (lazertinib).
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At 12 months, 65% of patients receiving SC were alive, compared with 51% treated with IV.
On Thursday, the FDA also approved an expanded indication for Johnson & Johnson’s TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery (MMA) for symptomatic subacute and chronic Subdural Hematoma (cSDH) as an adjunct to surgery.
cSDH is often caused by minor head trauma that leads to bleeding between the dura and arachnoid membranes, particularly among older adults and those on anticoagulation therapy.
While surgical intervention is the traditional standard of care, recurrence rates range from 10% to 20%.
Embolization of the MMA offers a minimally invasive endovascular approach by targeting smaller brain vessels thought to contribute to hematoma persistence and regrowth.
Findings from the MEMBRANE trial support the approval. The data showed that TRUFILL n-BCA is superior in effectiveness compared to the Standard of Care.
TRUFILL n-BCA was demonstrated to be safe for treating cSDH2.
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, according to Benzinga Pro data.
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