The FDA in March converted Johnson & Johnson’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod. But the door to an accelerated approval in the same indication remains open, according to Dizal Pharma.
Golidocitinib Green Lit by China’s NMPA for Relapsed/Refractory PTCL
SHANGHAI, June 2, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, presented the latest data from the inaugural global pivotal study WU-KONG1 Part B (WU-KONG1B) of sunvozertinib in relapsed or refractory non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrated statistically significant outcomes on the primary endpoint for sunvozertinib and highlighted its significant clinical value to patients around the globe.
SHANGHAI, May 24, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new medicines for the treatment of cancer and immunological diseases, announced new findings from a biomarker study in non-small cell lung cancer (NSCLC) patients with exon 20 insertion (exon20ins) mutations, highlighting sunvozertinib as an effective treatment for this patient population. The findings have been published in an abstract (#8563) available on the official website of the 2024 American Society of Clinical Oncology's (ASCO) Annual Meeting.
SHANGHAI, April 24, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new medicines for the treatment of cancer and immunological diseases, announced today that two abstracts featuring the latest data on sunvozertinib in non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on May 31 through June 4 in Chicago.
SHANGHAI, Dec. 13, 2023 /PRNewswire/ -- Dizal today announced that the results of a phase 2 pivotal study of sunvozertinib for the treatment of platinum-pretreated non-small-cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins) (WU-KONG6) were published in the peer-reviewed journal The Lancet Respiratory Medicine (IF: 76.2). The publication of these research results further reinforces sunvozertinib's leading position as a potential best-in-class treatment option, following its selection for an oral presentation at this year's ASCO Annual Meeting.
SHANGHAI, Dec. 12, 2023 /PRNewswire/ -- Dizal presented compelling data from its robust portfolio of hematological oncology at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition held in San Diego, California from December 9-12. The data showcased updated results of Dizal's two leading assets: golidocitinib, the first and only JAK1 selective inhibitor for the treatment of peripheral T-cell lymphoma (PTCL), and DZD8586, a first-in-class LYN and BTK dual inhibitor for the treatment of relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL). This underscores Dizal's dedication to developing and delivering innovative, life-changing medicines in the field of hematological oncology.
Dizal said its peripheral T-cell lymphoma drug candidate showed positive efficacy and safety in a Phase II registrational trial, paving the way for a US filing in what has been a challenging indication to secure full approval.
Just as the FDA revisits two accelerated approvals in peripheral T cell lymphoma (PTCL), AstraZeneca spinout Dizal Pharmaceutical is charting its own path for a potential conditional nod in the blood cancer.