FDA Approves 5-Minute Lung Cancer Drug, Revolutionizing Patient Care

SAN DIEGO, CA – December 18, 2025 – By Kenneth Walker

The U.S. Food and Drug Administration (FDA) has approved a new therapy for a common form of lung cancer that dramatically transforms the treatment experience, reducing administration time from several hours to approximately five minutes. The landmark approval of Johnson & Johnson's RYBREVANT FASPRO™ marks a pivotal moment for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), offering the first-ever targeted therapy for this group that can be delivered via a simple subcutaneous injection.

The new formulation, co-developed with Halozyme Therapeutics' ENHANZE® drug delivery technology, is approved for all indications where the intravenous version, RYBREVANT®, was previously used. Beyond the staggering reduction in administration time, clinical data demonstrated an approximately fivefold decrease in administration-related reactions, a common and burdensome side effect of the intravenous form. This dual benefit of speed and safety is poised to reshape the standard of care, shifting focus toward patient quality of life without compromising efficacy.

A New Era for Patient Convenience and Safety

For thousands of patients battling locally advanced or metastatic NSCLC, a cancer diagnosis often means their lives become tethered to hospitals and infusion centers. The original intravenous (IV) formulation of RYBREVANT (amivantamab-vmjw) required lengthy sessions, with patients spending hours connected to an IV drip. This not only consumed valuable time but also increased the risk of infusion-related reactions, which could range from mild discomfort to severe complications.

RYBREVANT FASPRO™ fundamentally alters this dynamic. The subcutaneous injection, administered just under the skin, frees patients from the infusion chair and significantly reduces their time in a clinical setting. This change represents a profound improvement in quality of life, allowing individuals to reclaim hours of their day for family, work, or personal pursuits.

Furthermore, the clinical evidence supporting the approval highlighted a dramatic improvement in safety and tolerability. The Phase 3 PALOMA-3 study reported that administration-related reactions occurred in only 13 percent of patients receiving the subcutaneous version, compared to a staggering 66 percent in the IV arm. This reduction alleviates a major source of anxiety and physical distress for patients and simplifies treatment management for healthcare providers. For oncology clinics, the shift from a multi-hour infusion to a five-minute injection also promises to improve operational efficiency, freeing up vital resources and allowing them to serve more patients.

The Technology Behind the Transformation

This medical breakthrough was made possible by an innovative drug delivery platform from San Diego-based Halozyme Therapeutics. The company's ENHANZE® technology is the unsung hero behind RYBREVANT FASPRO™. It utilizes a proprietary enzyme, rHuPH20, which temporarily breaks down a component of the tissue under the skin. This allows for the rapid dispersion and absorption of large-volume biologic drugs, like amivantamab, that would otherwise have to be administered intravenously.

"Formulated with our leading ENHANZE drug delivery technology, RYBREVANT FASPRO™ has the potential to make administration faster and more convenient for patients and their families compared to intravenous administration," said Dr. Helen Torley, president and chief executive officer of Halozyme, in a statement. She noted that the technology could also "support efficiencies for healthcare providers and lower costs for the healthcare system."

The approval serves as powerful validation for Halozyme's platform, which is licensed to numerous leading pharmaceutical companies, including Roche, Takeda, and Pfizer, for use in over ten commercialized products globally. This latest success with a major oncology drug reinforces the technology's potential to redefine treatment across a wide spectrum of diseases by converting burdensome IV therapies into patient-friendly subcutaneous options.

Shaking Up a Competitive Oncology Market

The approval of RYBREVANT FASPRO™ strategically positions Johnson & Johnson in the highly competitive market for EGFR-mutated NSCLC. This space has been largely dominated by AstraZeneca's oral medication, Tagrisso (osimertinib), a multi-billion dollar drug that set a high bar for both efficacy and convenience. While the original IV version of Rybrevant demonstrated strong clinical results, its cumbersome administration method was a significant barrier to wider adoption.

By resolving this key challenge, Johnson & Johnson can now compete more directly on clinical merit. Data from the MARIPOSA study has already shown that a combination of Rybrevant and lazertinib improved progression-free survival over Tagrisso in the first-line setting. With the new, more convenient formulation, physicians and patients may be more inclined to choose the Rybrevant-based regimen. This approval is a critical component of Johnson & Johnson's ambitious strategy to achieve $50 billion in oncology sales over the next several years.

For Halozyme, the success translates into a strengthened revenue stream through royalties on Johnson & Johnson's sales, further cementing its business model as a key enabler of next-generation therapeutics. The approval is also a significant win for Johnson & Johnson, which successfully resubmitted its application after the FDA initially rejected it over manufacturing quality concerns, demonstrating the company's commitment to bringing this improved formulation to market.

Robust Clinical Data Validates a Superior Option

The FDA's decision was based on the robust results of the Phase 3 PALOMA-3 study, which enrolled 418 patients with EGFR-mutated NSCLC. The trial was designed to prove that the subcutaneous formulation was "non-inferior" to the IV version, meaning it delivered a comparable amount of the drug into the bloodstream. The study successfully met these primary pharmacokinetic endpoints.

However, subsequent data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology revealed an even more compelling story. The subcutaneous formulation was not just more convenient—it was associated with better clinical outcomes. Patients in the subcutaneous arm demonstrated a longer duration of response, improved progression-free survival, and a statistically significant improvement in overall survival compared to those on the IV formulation. The 12-month overall survival rate was 65 percent for the subcutaneous group versus 51 percent for the IV group, suggesting the new delivery method may offer more than just convenience.

While the overall safety profile was consistent with the known effects of amivantamab, including common side effects like rash and nail changes, the significant reduction in administration-related reactions remains the standout safety benefit. This combination of superior convenience, enhanced safety, and potentially improved efficacy makes RYBREVANT FASPRO™ a transformative new option in the fight against lung cancer.