Positive breakthrough for new lung cancer drug developed at The Royal Marsden
Professor Sanjay Popat, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust is lead reseracher on new drug developed for lung cancer treatment
The safety profile of ALUNBRIG in the ALTA-1L trial was generally consistent with the existing European summary of product characteristics (SmPC). The most common treatment-emergent adverse events (TEAEs) Grade ≥3 in the ALUNBRIG arm were increased CPK (24.3%), increased lipase (14.0%) and hypertension (11.8%); and for crizotinib were increased ALT (10.2%), increased AST (6.6%), and increased lipase (6.6%).
“Developing safe and effective treatment options for cancer is a top priority for Takeda, and we continue to look for ways to address the unmet needs of the lung cancer community,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “Today’s positive CHMP opinion is an important step towards bringing ALUNBRIG to people living with ALK+ advanced NSCLC, and we look forward to continuing to work with the EMA as they review the application for ALUNBRIG as a first-line treatment of patients with this serious and rare form of lung cancer.”
“ALK+ NSCLC is a rarer form of lung cancer, and the needs of people impacted by it are multiple,” said Stefania Vallone, President of Lung Cancer Europe (LuCE). “Despite progress in recent years, there remains a need for additional first-line treatment options for the approximately 10,000 people with ALK+ NSCLC in Europe.”
The positive opinion for ALUNBRIG will now be reviewed by the European Commission (EC) for Commission Decision. ALUNBRIG is currently not approved as a therapy for first-line ALK+ NSCLC.