Amivantamab-VMJM

Johnson & Johnson's Rybrevant-Lazcluze combo has beat Tagrisso on efficacy, reducing patients’ risk of death by 25% for the first-line treatment of EGFR-mutated non-small cell lung cancer. A year after an FDA rejection, Johnson & Johnson has won approval for a more convenient version of its lung cancer drug Rybrevant to better challenge AstraZeneca’s Tagrisso.Rybrevant Faspro, a subcutaneous formulation of Rybrevant, is now cleared in the same indications as the original intravenous infusion, including its use alongside J&J’s Lazcluze for the first-line treatment of EGFR-mutated metastatic non-small cell lung cancer (NSCLC).Compared with the original Rybrevant, the under-the-skin version reduces the antibody drug’s administration time from several hours to about five minutes, which J&J suggests is more convenient for patients and less burdensome for healthcare resources.“This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment,” Joelle Fathi, chief healthcare delivery officer at GO2 for Lung Cancer, a patient support group, said in a Dec. 17 statement.The approval arrives a year after FDA inspection findings at a manufacturing facility led to a complete response letter for subcutaneous Rybrevant, which was developed using Halozyme Therapeutics’ Enhanze drug delivery technology.J&J hopes the latest Faspro offering can repeat the success of the company’s blockbuster multiple myeloma drug Darzalex Faspro. But, unlike the almost-unchallenged anti-CD38 drug, Rybrevant faces an uphill fight against AZ’s Tagrisso and the dominant EGFR inhibitor’s latest combination with chemotherapy.J&J’s Rybrevant-Lazcluze combo already beat Tagrisso on efficacy, reducing patients’ risk of death by 25% in the phase 3 Mariposa trial in first-line EGFR-mutated NSCLC. But Tagrisso’s convenience as a once-daily tablet and its well-understood safety profile could still make persuading doctors to switch to Rybrevant-Lazcluze an arduous process for J&J. On the safety side, Rybrevant Faspro is an improvement from infused Rybrevant, thanks to its ability to reduce the rate of administration-related reactions to 13% from 66%, according to results from the phase 3 Paloma-3 trial. The study compared the two versions of amivantamab in their separate combinations with Lazcluze in previously treated EGFR-mutated NSCLC.Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, was also lower, at 11%, for the combo with subcutaneous Rybrevant, versus 18% observed in patients who received the intravenous formulation in Paloma-3.But VTE could be an Achilles’ heel of J&J’s Rybrevant regimen in its ongoing battle against Tagrisso. In the Mariposa trial in the first-line setting, intravenous Rybrevant and Lacluze were linked to a 36% VTE rate, whereas only 9% of Tagrisso takers experienced VTE. As a result, prophylactic anticoagulation is recommended for the first four months of treatment with Rybrevant or Rybrevant Faspro.To prop up Tagrisso’s efficacy, AZ last year won the FDA’s approval for its use alongside chemotherapy after the phase 3 Flaura2 trial showed that the combo reduced the risk of disease progression or death by 38% compared with Tagrisso alone. Then, earlier this year, AZ reported that the trial met its overall survival endpoint, with the combo boasting a 23% death risk reduction versus Tagrisso monotherapy.J&J has argued that patients do not want to take chemotherapy upfront given its toxicity. Now, with Rybrevant Faspro, the administration time of the J&J regimen is also shorter than chemo, which the company said could take up to an hour. Rybrevant Faspro may also hold an efficacy advantage over the original Rybrevant. In the Paloma-3 trial, the two formulations showed similar pharmacokinetic results as measured by amivantamab levels in the blood. But overall survival data were surprisingly better for patients treated with Rybrevant Faspro, with a 38% death risk improvement.J&J has hypothesized that subcutaneous absorption of the drug may potentially enhance immune-mediated anticancer activity. This survival finding was drawn from the second-line setting, and it was not included in Rybrevant Faspro’s label.Before the latest nod, Rybrevant and Lazcluze together brought in $136 million in U.S. sales in the third quarter, versus $139 million in the second quarter and $113 million in the first.In the first nine months of 2025, Tagrisso increased sales by 11% year over year in the U.S., reaching $2.2 billion, as AZ touted the Flaura2 regimen as the leading combo in first-line EGFR-mutated NSCLC.

RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).1 RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) and represents the first and only subcutaneously (SC) administered targeted therapy for patients with EGFR+ mNSCLC. Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ significantly reduced administration time from several hours to approximately five minutes and demonstrated an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm). "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. "By reducing administration times and simplifying the treatment experience, ENHANZE-formulated products could also support efficiencies for healthcare providers and lower costs for the healthcare system. This approval underscores ENHANZE's role in delivering meaningful clinical and economical value for patients, providers and payers." Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].1,2 For more information on this approval, please view Johnson & Johnson's press release issued on December 17, 2025. References 1.RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 2.Yang J et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line EGFR-mutant Advanced NSCLC – Final Overall Survival from MARIPOSA [ELCC abstract #40]. Presented at: 2025 European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V. Halozyme is also developing Hypercon™ to expand the breadth of its drug delivery technology portfolio. Hypercon™ is an innovative microparticle technology that is expected to set a new standard in hyper concentration of drugs and biologics that can reduce the injection volume for the same dosage and expands opportunities for at-home and health care provider administration. The addition of Hypercon™ enhances our ability to transform the patient treatment experience by enabling the creation and delivery of highly concentrated biologics, substantially broadening the scope of therapeutics that can be delivered subcutaneously. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson, Eli Lilly, and argenx. Halozyme also develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability, and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products, and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility. For more information, visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and administration-related reactions, broadening the treatment options for the indications referred to in this press release, support efficiencies for healthcare providers and potentially lower healthcare system costs. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo