The Center for Drug Evaluation (CDE) website indicates that Swiss giant Roche’s (SWX: ROG) glofitamab (RO7082859) and China-based Dizal Pharmaceutical Co., Ltd’s sunvozertinib (DZD9008) are set to enter the priority review process. This marks a significant step forward for both drugs, which are poised to address significant unmet needs in oncology.
Roche’s Glofitamab: Mechanism and Indications
Glofitamab (RO7082859) is a bispecific antibody (BsAb) developed via Roche’s TCB technology platform, featuring two CD20 binding sites and one CD3 binding site. Compared to traditional 1:1 BsAbs, glofitamab has a higher binding affinity for CD20 on the surface of B cells, which can induce rapid T cell activation and cytokine release, leading to target cell lysis. The 2:1 double antibody structure also offers the advantage of being suitable for combination use with other anti-CD20 antibodies, providing the possibility for the development of combined treatment programs. Glofitamab received breakthrough therapy designation (BTD) for use in adult patients with recurrent or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of treatment, including non-specific diffuse large B-cell lymphoma (DLBCL-NOS), high-grade B-cell lymphoma (HGBCL), follicular lymphoma transformed DLBCL (trFL), and primary mediastinal large B-cell lymphoma (PMBCL). The priority review is for the indication of recurrent or refractory DLBCL and PMBCL in patients who have previously received at least two lines of systemic treatment.
Dizal’s Sunvozertinib: Mechanism and Indications
Sunvozertinib, a next-generation epidermal growth factor receptor (EGFR) inhibitor, is the only home-grown drug with BTD status in China and the US in the lung cancer field. The drug is currently undergoing a global multi-center regulatory study and has obtained approval for a Phase II study in non-small cell lung cancer (NSCLC) with EGFR mutation and standard treatment failure, in combination with golidocitinib. The priority review status is awarded for the drug’s development as a treatment for adults with locally advanced or metastatic NSCLC with disease progression or intolerance to platinum-containing chemotherapy, with confirmed insertion mutation of EGFR exon 20.
Future Outlook
The entry of Roche’s glofitamab and Dizal’s sunvozertinib into the priority review process underscores the potential of these innovative therapies to improve patient outcomes in challenging oncology indications. With their respective breakthrough therapy designations and demonstrated efficacy, both drugs are poised to make a significant impact in their target patient populations. The CDE’s priority review status highlights the importance of accelerating the availability of these therapies to patients in need.-Fineline Info & Tech
