Janssen
FDA Warns of T-Cell Malignancy Risk Following Autologous CAR T-Cell Therapy
Although the agency said the benefits of these treatments still outweigh their risks, it is investigating the potential for serious adverse outcomes and assessing the need for regulatory action.
Janssen Seeking FDA Approval for Rybrevant-Chemo in EGFR-Mutated NSCLC After Prior Tagrisso Therapy
The firm filed a supplemental biologics licensing application seeking approval for the combination based on data from the Phase III MARIPOSA-2 clinical trial.
Phase III Data at ESMO Support Rybrevant-Chemo as First-Line Therapy in Lung Cancer Subgroup
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Treatment-naïve NSCLC patients with EGFR exon 20 insertion mutations had better median progression-free survival on the regimen compared to chemo alone.
J&J Oncology Revenues Jump 12 Percent in Q3
The firm touted sales gains for Carvykti and highlighted regulatory updates for Akeega, Balversa, and Rybrevant in Q3.
Janssen Seeking Rybrevant-Chemo Approval in Europe for First-Line EGFR-Mutated NSCLC
The drugmaker has filed an application with the European Medicines Agency seeking approval for the regimen in NSCLC with EGFR exon 20 insertion mutations.