(News Bulletin 247) – OSE Immunotherapeutics announces today that AEMPS, the Spanish Medicines Agency, has made available a new early access program which will allow patients to have access to Tedopi® within the framework of a ‘special situation’ authorization for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) after failure of treatment with a checkpoint inhibitor (CPI).
The laboratory specifies that this authorization for “special situation” is based on the positive data of a phase 3 trial.
OSE Immuno recalls that Tedopi® is ‘the first therapeutic vaccine against cancer having shown positive and clinically relevant efficacy results associated with a significant gain in survival and a better tolerance profile and quality of life in patients suffering from ‘an advanced NSCLC’.
‘The Spanish Medicines Agency’s decision to approve Tedopi® will facilitate early access to treatment pending its marketing authorization and represents a significant benefit for third-line patients, in post secondary resistance. -sequential treatment with chemotherapy and immunotherapy’, explained in substance Dr. Santiago Viteri, Medical Director of the UOMI Cancer Center, Clinica Mi Tres Torres, Barcelona.
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