Chris Ryan

2 months ago | chrisryan.substack.com | Chris Ryan

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Jan 3, 2025 | onclive.com | Chris Ryan

Treatment with the Claudin18.2 (CLDN18.2)–directed autologous CAR T-cell therapy satricabtagene autoleucel (satri-cel; CT041) led to a statistically significant improvement in progression-free survival (PFS) compared with physician’s choice of therapy in patients with CLDN18.2-positive advanced gastric/gastroesophageal junction (GEJ) cancer that had progressed following at least 2 prior lines of therapy, according to topline data from the phase 2 CT041-ST-01 trial (NCT04581473).1 Findings...

Jan 2, 2025 | onclive.com | Chris Ryan

The FDA has received a new drug application (NDA) seeking the accelerated approval of dordaviprone (ONC201) for the treatment for patients with recurrent H3K27M-mutant diffuse glioma.1Chimerix, the developer of dordaviprone, has requested priority review of the NDA by the regulatory agency, which would lead to a potential Prescription Drug User Fee Act target action date in the third quarter of 2025.

Dec 23, 2024 | onclive.com | Chris Ryan

The FDA has granted priority review to the new drug application (NDA) seeking the approval of taletrectinib for the treatment of patients with ROS1-positive advanced non–small cell lung cancer.1The NDA is supported by data from a pooled analysis of the phase 2 TRUST-1 (NCT04395677) and TRUST-II (NCT04919811) trials.

Dec 20, 2024 | onclive.com | Chris Ryan

The addition of dostarlimab-gxly (Jemperli) to standard-of-care platinum-based chemotherapy and niraparib (Zejula) maintenance, with or without bevacizumab (Avastin), led to a statistically significant improvement in progression-free survival (PFS) compared with chemotherapy followed by niraparib maintenance alone, meeting the primary end point of the phase 3 FIRST trial (NCT03602859).1 However, regarding the trial’s key secondary end point of overall survival (OS), a statistically...