Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma

Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company is expected to submit MAA to EMA in H1’21 The accelerated approval milestone in EU follows the rolling submission for cilta-cel to the US FDA in Dec’2020 Cilta-cel is an …

Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma Read More »