Positive CHMP approval for Takeda’s Alunbrig in ALK+ advanced non-small lung cancer

pharmafile | March 4, 2020 | News story | Research and Development CHMP, EMA, Takeda, lung cancer, pharma 

Takeda’s Alunbrig (brigatinib) has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), it has emerged. The committee chose to give a positive opinion for the drug as a monotherapy in the treatment of anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in adult patients who have not previously received an ALK inhibitor.

The decision was based on Phase 3 comparing Alunbrig to crizotinib in the same indication. The findings for Alunbrig showed a 69% reduction in risk of intracranial disease progression or death in patients with brain metastases according to a blinded independent review committee, and a 76% reduction according to investigators.

The drug also demonstrated a median progression-free survival of 24 months, more than double the 11 months presented by crizotinib.

“Because of the complex nature of ALK+ NSCLC and the way in which the disease often spreads to the brain, it is essential for physicians to have treatment options that demonstrate both overall and intracranial effectiveness,” explained Professor Sanjay Popat, Consultant Medical Oncologist, Royal Marsden NHS Foundation Trust. “In the ALTA-1L trial, brigatinib demonstrated significant responses in the brain and consistent overall efficacy compared to crizotinib. If approved by the EMA, brigatinib has the potential to become an important option for the first-line treatment of ALK+ advanced NSCLC patients in Europe.”

Christopher Arendt, Head, Oncology Therapeutic Area Unit at Takeda, also remarked on the decision: “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. 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.”

Matt Fellows

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