Expert Discusses FDA Approval of Chemo-Free Option for EGFR-Mutated Lung Cancer

The FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the first and only subcutaneous, chemo-free treatment for patients with EGFR-mutated non-small cell lung cancer across all indications, offering a five-minute administration time and fewer infusion-related reactions that may reduce treatment burden.

In an interview with CURE, Joelle Thirsk Fathi, a board-certified and practicing nurse practitioner and Chief Healthcare Delivery Officer for GO2 for Lung Cancer, said the approval is clinically meaningful not only for outcomes but for patient experience.

She noted that shorter administration times and fewer reactions can lessen the physical and emotional burden of care for patients and caregivers, particularly for those newly starting treatment. Fathi added that a chemo-free, subcutaneous option may help patients maintain daily routines while easing strain on treatment centers.

CURE: Why is the FDA approval of a chemo-free subcutaneous option for EGFR-mutated non-small cell lung cancer such a meaningful moment for patients and caregivers?

Fathi: Well, first and foremost, I would say that the data that recently came out with this approval is just downright clinically meaningful for patients. We know that EGFR-mutated non-small cell lung cancer (NSCLC) is one of the more commonly occurring driver mutations that we see. It is exciting that we now have chemo-free targeted therapies that promise to improve not only the quality of life but also the overall experience when receiving this subcutaneous formulation for the vast number of people who have EGFR-mutated NSCLC.

Many patients cite treatment burden as a major concern as they go through any kind of cancer care. So how could this five-minute administration time and fewer infusion-related reactions change the day-to-day experience of living with advanced lung cancer?

When I’m looking at this from a nurse practitioner's standpoint, when we’re at the end of diagnosing and treating people, we have a lot to be concerned about: the mechanism of action, tolerability, treatment effectiveness, and ease of administration. From a patient's perspective, the important factors are the physical and emotional burdens of the treatment. Especially for first-timers, people coming into treatment for the first time, the fear of the unknown can be daunting.

As health care providers, we need to think about the treatments available to patients, the choices we make for them, and what we’re offering them. In this process, it is important to discuss the health outcomes of the subcutaneous option, which are better than those of the IV formulation and other treatment options, and to recognize the potential physical and emotional experiences for our patients when choosing one formulation over another.

That’s a long-winded way to say that where we’re at currently in this landscape with this novel targeted therapy and modality of treatment, these things matter for patients. That experience for people is just as important as the decision-making on the provider side when we’re choosing what we believe to be the right treatment, at the right time, for the right outcomes, and the patient experience they desire.

What it boils down to is the lived reality for patients and their caregivers. We think about patients, but we also focus on caregivers and what that experience is like for them. That looks different with chemotherapy versus a targeted therapy, like Rybrevant.

But also, who has time to be sick? Most people are juggling families and have complex schedules. It’s never convenient to go to clinics. In this day and age, we face workforce shortages, health systems are more strained than ever, and challenges in accessing treatment centers are growing.

The exciting thing about subcutaneous administration is that it not only eases the burden on patients' scheduling but also on the provider side at the treatment center. We also know, from the outcomes data, that it reduces the likelihood that people will have treatment-related side effects that require more time to care for.

In addition to being a more patient-centered option, it improves the overall experience for patients, caregivers, providers, and health systems, easing the path for everyone. You can’t argue with a five-minute subcutaneous administration over several hours, taking up chair time in a treatment center.

How does this approval help address long-standing unmet needs in the treatment landscape for EGFR-mutated non-small cell lung cancer?

When we’re looking at advanced-stage disease, we need to balance treatments with quality of life. Advanced-stage disease looks different than early-stage lung cancer, and this gets back to the points I made earlier about balancing the demands of health, treatment, wellness, and quality of life. The exciting thing about this formulation is that it holds the possibility to positively contribute to all these priorities.

It offers improved administration-related reactions, which translate to quality of life, patient comfort, and greater predictability in what we can expect from subcutaneous administration of this chemo-free formulation. But we can also count on durability, progression-free survival and overall survival in the setting of advanced-stage EGFR-mutated non-small cell lung cancer.

This formation sets a new standard for what we should be aiming for and expect for patient-centered care in the 21st century.

Advocacy groups often hear directly from patients about quality-of-life concerns. What reactions are you hearing from the community regarding the availability of this chemo-free option?

I would be hard-pressed to say that I’ve ever met a patient who didn’t have reservations about undergoing chemotherapy treatment. Chemotherapy drugs are important and remain a critical component of treatment. That said, if people qualify and meet the clinical criteria for treatment with a less toxic drug that can be as effective or more effective, it makes sense to reach for a formulation like subcutaneous Rybrevant.

Chemotherapy is often one of the most feared aspects of cancer treatment, and those harsh side effects translate to loss of control over lives and well-being. I’ve had patients who decided years ago that they weren’t willing to pursue treatment. Now, people can receive treatment knowing up front that it will be easier to tolerate.

The availability of a chemo-free regimen like subcutaneous Rybrevant that can be delivered so quickly, with fewer reactions, resonates deeply with the lung cancer community. It also offers an opportunity to maintain normalcy, preserve energy and focus on what matters most, which translates to empowerment for patients throughout treatment.

How do you see this approval influencing future drug development and patient-centered care for lung cancer?

This success will likely accelerate the development of similar agents across drug classes and stages of lung cancer. This approval signals a shift toward a future in which effectiveness and quality of life are recognized as equally essential pillars of cancer care and achievable. Improved survival outcomes, shorter administration times, fewer reactions and greater flexibility are realistic expectations now.

This also shapes the future of personalized medicine for actionable mutations and may set a new standard even for patients without targetable alterations. It pushes everyone to think differently about what’s possible and to prioritize patient-centered care moving forward.

References

1. “U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when combined with LAZCLUZE® (lazertinib),” by Johnson & Johnson. News release; Dec. 17, 2025.

Transcript has been edited for clarity and conciseness.

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