ImmunityBio resubmits FDA application for ANKTIVA in bladder cancer after agency requests updated efficacy data

ImmunityBio resubmits FDA application for ANKTIVA in bladder cancer after agency requests updated efficacy data

ImmunityBio has resubmitted its supplemental biologics license application to the U.S. Food and Drug Administration for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guerin for BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors, after the agency requested updated long-term efficacy data in March 2026. The resubmission follows a regulatory exchange that began in January […]

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

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 […]