ARIAD Pharmaceuticals has asked the European Union to approve the marketing of its investigational therapy brigatinib for lung cancer.
The European Medicines Agency (EMA) will recommend whether the EU should authorize brigatinib for those with ALK-positive non-small cell lung cancer (NSCLC) who received prior treatment with Xalkori (crizotinib).
The Food and Drug Administration is reviewing a similar application for sales of brigatinib in the United States. It plans to make a decision by April 29, 2017.
“ARIAD’s submission of the brigatinib MAA [Marketing Authorization Application]to the EMA is one of many recent milestones highlighting our strong investment in internally discovered rare cancer therapies,” Paris Panayiotopoulos, the company’s president and chief executive officer, said in a news release. “Since announcing our definitive agreement to combine with Takeda, we remain focused on our accountability to our patients by propelling brigatinib forward and by preparing for its anticipated U.S. launch.”
Nearly 5 percent of NSCLC patients have a chromosomal alteration in their ALK gene that is believed to be a driver of the cancer. Two ALK inhibitors are FDA-approved to treat ALK-positive NSCLC — Xalkori and Zykadia (ceritinib).
Brigatinib has emerged as a potential treatment for patients resistant to other ALK inhibitors.
The European application included data from ARIAD’s Phase 1 and 2 trial and from a global Phase 2 ALTA (NCT02094573) trial. The ALTA trial divided 222 patients with locally advanced NSCLC or cancer that had spread into two randomly assigned groups. Cohort A received 90 mg of brigatinib once a day. Cohort B received 90 mg a day for seven days, followed by 180 mg a day for 28 days.
After a median follow-up of 11 months, 55 percent of Cohort B patients achieved a full or partial response to the treatment. In addition, 67 percent of patients with measurable brain metastasis — or spread of the cancer to the brain — achieved a confirmed intracranial objective response, including intracranial progression-free survival of 18.4 months. Median progression-free survival in the cohort was 15.6 months.
The most common treatment-related adverse events were nausea, diarrhea, cough, headache, hypertension, pneumonia, and an increase in the levels of two enzymes.
“The brigatinib clinical trials have provided patients with refractory ALK+ NSCLC, including those patients who have metastatic brain lesions, with a potential important treatment option,” said Maurice Perol, MD, of the Léon Bérard Cancer Center in Lyon, France. “Based on the clinical data we’ve seen to date, we are really excited by the prospect that appropriate patients in the EU may have access to brigatinib as a new targeted treatment.”