J&J’s amivantamab shows strong first-line response in metastatic colorectal cancer

By on    Pharma & Biotech  

J&J’s amivantamab shows strong first-line response in metastatic colorectal cancer

Johnson & Johnson (J&J) has reported updated results from its Phase 1b/2 OrigAMI-1 trial evaluating amivantamab-vmjw in combination with chemotherapy for patients with RAS/BRAF wild-type metastatic colorectal cancer. The bispecific antibody, which targets epidermal growth factor receptor (EGFR) and MET, achieved confirmed response rates of 73 percent in the first-line setting and 44 percent in […]

J&J ends JNJ-5939 trial early in atopic dermatitis after missing efficacy mark

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J&J ends JNJ-5939 trial early in atopic dermatitis after missing efficacy mark

Johnson & Johnson (J&J) announced that its investigational candidate JNJ-95475939 (JNJ-5939) failed to meet prespecified efficacy criteria in the DUPLEX-AD Phase 2b trial for moderate to severe atopic dermatitis. Following an interim analysis, the study was terminated early. Despite showing a favorable tolerability profile, the molecule did not demonstrate sufficient clinical efficacy to warrant continuation. […]

FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

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FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics […]

FDA approval gives J&J’s AKEEGA a first-mover edge in BRCA2-mutated metastatic prostate cancer

By on    Pharma & Biotech  

FDA approval gives J&J’s AKEEGA a first-mover edge in BRCA2-mutated metastatic prostate cancer

Johnson & Johnson (J&J) announced on December 12, 2025, that the U.S. Food and Drug Administration approved AKEEGA, a dual-action tablet combining niraparib and abiraterone acetate, alongside prednisone, for treating BRCA2-mutated metastatic castration-sensitive prostate cancer. The regulatory nod, based on the pivotal AMPLITUDE trial, makes AKEEGA the first precision medicine combination approved for this high-risk […]

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