Roche announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alecensa (alectinib) as monotherapy, as adjuvant therapy in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence.

According to Roche, Alecensa could change the current standard of care for people with ALK-positive NSCLC resected at an early stage by reducing the risk of disease recurrence or death by 76%.

"The CHMP's recommendation for Alecensa adjuvant marks an important step towards providing an effective new treatment for people with early-stage NSCLC, which could improve outcomes through a targeted, biomarker-based therapeutic approach," commented Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.


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