The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s Talvey (talquetamab) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) are on track to receive priority review statuses. Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, is in development for the treatment of adult patients with recurrent/refractory multiple myeloma (MM) who have received at least three prior lines of treatment, including a proteasome inhibitor, an immune modulator, and a CD38 antibody. The priority status reflects the filing’s breakthrough therapy designation (BTD) and potential for conditional approval.
Enhertu, an anti-HER2 antibody drug conjugate (ADC), is also poised for a BTD filing and potential conditional approval as a treatment for adults with unresectable or metastatic adult non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activation mutation, who have previously received at least one systemic treatment.
Talquetamab received accelerated approval in the US in August 2023 as a fifth-line treatment for recurrent or refractory MM. Enhertu, co-developed by UK major AstraZeneca, was first approved in China in February 2023 to treat irresectable or metastatic HER2 positive adult breast cancer patients who had previously been treated with an anti-HER2 therapy. The drug received another indication nod in July 2023 for the treatment of breast cancer with unresectable or metastatic HER2 low expression (IHC 1+ or IHC 2+/ISH -) in patients who had previously been treated with at least one systemic treatment in the metastatic stage, or who had recurred during adjuvant chemotherapy or within 6 months after completing adjuvant chemotherapy.- Flcube.com
