J&J's 5-Minute Subcutaneous Lung Cancer Therapy Rybrevant Faspro Approved, Taking on AstraZeneca's Tagrisso

Dec 19, 2025 22:35 CST Updated 22:35

Johnson & Johnson

Medical Device R&D and Manufacturer

AstraZeneca

Pharmaceutical Technology Research and Development Provider

Abstract:A Year Later, Johnson & Johnson’s Subcutaneous Formulation of Lung Cancer Drug Rybrevant Faspro Receives FDA Approval. This formulation reduces administration time from several hours to approximately 5 minutes and improves safety, aiming to challenge AstraZeneca's Tagrisso in the EGFR-mutated metastatic non-small cell lung cancer treatment field. This showdown between giants is not only about market share but will also bring a new transformation in treatment options for patients.

Approval Delayed by a Year: Convenience Becomes the Core Highlight

Last year, the subcutaneous formulation of Rybrevant failed to gain FDA approval due to issues with the inspection of its production facilities. Now, this new drug, which utilizes Halozyme Therapeutics' Enhanze drug delivery technology, has finally received approval. Its approved indications are consistent with the original intravenous formulation, including use in combination with another Johnson & Johnson drug, Lazcluze, for first-line treatment of EGFR-mutated metastatic non-small cell lung cancer.

Most noteworthy is the innovation in the method of administration. The original Rybrevant intravenous infusion takes several hours, while the subcutaneous injection version can be completed in about 5 minutes. Dr. Joelle Fathi, Chief Medical Officer of GO2 for Lung Cancer, a lung cancer patient support organization, stated that this therapy reduces the physical and mental burden of prolonged infusion, allowing patients and their families to reclaim precious time and focus on life rather than treatment.

Safety and Efficacy: Advantages and Concerns Coexist

Paloma-3 Phase III clinical trial data show that Rybrevant Faspro is significantly safer than the intravenous infusion version. The incidence of administration-related reactions decreased from 66% to 13%, and the incidence of venous thromboembolism (including deep vein thrombosis and pulmonary embolism) also dropped from 18% to 11%.

In terms of efficacy, the pharmacokinetic results of blood drug concentrations for the two dosage forms were similar. However, the subcutaneous injection version showed unexpectedly better overall survival, reducing the risk of death by 38%. Johnson & Johnson speculated that subcutaneous administration might enhance immune-mediated anti-cancer activity, but this survival data was not included in the drug labeling.

But venous thromboembolism remains its weakness. In the Phase III Mariposa trial for first-line treatment, the incidence of thrombosis with intravenous Rybrevant combined with Lazcluze was as high as 36%, compared to only 9% in the Tagrisso group. Therefore, patients receiving treatment with the Rybrevant series of drugs need preventive anticoagulation during the first four months.

Market Showdown: Giants Compete in the Lung Cancer Arena

This approval means that Johnson & Johnson has officially launched a challenge against AstraZeneca's Tagrisso. In the previous Mariposa trial, Rybrevant combined with Lazcluze had already outperformed Tagrisso in efficacy, reducing the risk of patient death by 25%.

But Tagrisso's advantages are also evident: the convenience of once-daily oral administration, mature safety data, and after being approved in combination with chemotherapy last year, it reduced the risk of disease progression or death by 38%. This year, even better news came with overall survival benefits and a 23% reduction in the risk of death. AstraZeneca positions it as the preferred combination for first-line treatment.

Johnson & Johnson countered that the toxicity of chemotherapy makes patients reluctant to use it upfront, whereas Rybrevant Faspro not only eliminates the need for chemotherapy but also has a shorter administration time (about 5 minutes) compared to chemotherapy's longest duration of one hour.

In terms of market performance, in the first three quarters of this year, Tagrisso's sales in the United States reached 2.2 billion US dollars, increasing by 11% year-on-year; while Rybrevant combined with Lazcluze achieved sales of 136 million US dollars in Q3, 139 million US dollars in Q2, and 113 million US dollars in Q1 in the United States, still having significant room for growth. This giant competition in the field of lung cancer will bring more treatment options to patients and reshape the treatment landscape of EGFR-mutated non-small cell lung cancer.

Reference Source:https://www.fiercepharma.com/pharma/fda-approves-jj-subcutaneous-lung-cancer-shot-sharpening-its-challenge-tagrisso

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