Janssen
FDA Issues Complete Response to Johnson & Johnson's Application for Subcutaneous Rybrevant
The agency's decision not to approve this formulation was based on issues identified during a pre-approval inspection at a manufacturing facility, the firm said.
The iMMagine-1 data suggest anito-cel could have a differentiated safety and efficacy profile compared to available BCMA-directed therapies.
The data suggest that multiple myeloma patients on Janssen's CAR T-cell therapy lived longer than on BMS's but experienced more severe side effects.
The drugmaker met increased demand following approval of Carvykti in earlier lines of therapy with expanded production at US and European facilities.
Janssen's Rybrevant, Chemo Regimen Nets FDA Approval in EGFR-Mutated NSCLC
The agency reviewed data from the MARIPOSA-2 trial and approved the regimen for patients with common EGFR mutations who are progressing on EGFR inhibitors.