CHMP recommends EU approval of Roche ’s Alecensa as the first adjuvant treatment for resected ALK-positive early-stage lung cancer

If approved, Alecensa will be the first and only ALK inhibitor approved for people with resected ALK-positive early-stage non-small cell lung cancer (NSCLC)The positive recommendation is based on results from the Phase III ALINA study where Alecensa showed an unprecedented 76% reduction in the risk of disease recurrence or death, compared to adjuvant chemotherapy1With about half of people living with early-stage NSCLC experiencing disease recurrence or death following surgery, Alecensa could minimise the risk by treating NSCLC before it has spread2Basel, 26 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Alecensa® (alectinib) monotherapy, as adjuvant treatment following complete tumour resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk o f recurrence*. Cancer recurrence affects approximately half of all people with early-stage NSCLC following surgery, despite adjuvant chemotherapy, at which point the disease often becomes incurable.2-8 By treating NSCLC before it has spread to other parts of the body and reducing the chance of a person ’s cancer returning, Alecensa has the potential to change the current standard of care for people with resected ALK-positive early-stage NSCLC. A final decision is expected from the European Commission in the near future.“Minimi...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news