When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
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metastatic triple-negative breast cancer (mTNBC)
Trodelvy significantly improved overall survival and demonstrated clinically meaningful improvements in quality of life in Phase III study.
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
The dose-finding trial will evaluate the safety and activity of UniCAR-T-PSMA in up to 16 patients with advanced relapsed/refractory, PSMA-positive solid tumours.
Gilead is set to acquire Immunomedics for approximately $21 billion, with the transaction anticipated to close in the fourth quarter of 2020.
The drug’s developers reveal Keytruda increased progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) expressing PD-L1.