Amivantamab-VMJM

The study demonstrated that Rybrevant Faspro has met co-primary pharmacokinetic endpoints. Credit: Johnson & Johnson / PRNewswire. Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), a subcutaneously (SC) administered therapy to treat patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). The approval covers all existing indications for Rybrevant. The SC formulation reduces administration time from several hours to five minutes, compared to intravenous (IV) delivery, offering increased patient convenience and decreasing healthcare resource use. Rybrevant’s approval is supported by results from the Phase III PALOMA-3 study, which demonstrated that the therapy met both co-primary pharmacokinetic endpoints. These findings were initially presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology. Further PALOMA-3 data showed that the SC arm, in combination with Lazcluze (lazertinib), had longer overall survival (OS), longer duration of response, and improved progression-free survival compared to the IV arm. At 12 months, 65% of patients in the SC group were alive, against 51% in the IV group. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence J&J’s innovative medicine solid tumour president Biljana Naumovic said: “The approval of Rybrevant Faspro is a pivotal step forward, as EGFR+ NSCLC patients have previously faced limited treatment options. “Now, patients are gaining greater access to this transformative treatment, as well as the tools needed to proactively manage common dermatological effects.” The safety profile of Rybrevant Faspro in combination with Lazcluze was found to be largely consistent with IV administration. Common adverse reactions (≥ 20%) of the combination included musculoskeletal pain, haemorrhage, decreased appetite, and peripheral neuropathy. Last month, J&J signed a definitive agreement to acquire Halda Therapeutics (Halda) in a $3.05bn cash deal. Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact

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.