The U.S. Food and Drug Administration has given the 30mg and 90mg oral tablets of Alunbrig (brigatinib) accelerated approval for the treatment of anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer, or NSCLC.
Alunbrig will be the second-line treatment for ALK+ NSCLC patients who are intolerant to Pfizer's crizotinib or whose cases have progressed further.
FDA Accelerated Approval
The FDA's accelerated approval of the drug Alunbrig is based on meaningful results gathered from clinical trials that indicate a promising tumor response rate and duration of response.
The clinical trials involved 222 ALK+ NSCLC patients whose cases have progressed on or despite a crizotinib treatment. Of the 222 patients who were given a once-daily dose of either 90mg or a 180mg brigatinib, 219 were evaluated as safe.
"The rapid development of Alunbrig is a tribute to the dedication of many research scientists and clinicians who carefully designed and developed this new medicine to address unmet medical needs in the ALK+ NSCLC patient population. Most importantly, we would like to thank the patients and families who participated in the clinical trials," said Dr. Andy Plump, Takeda Pharmaceuticals chief medical and scientific officer.
What Is Alunbrig?
The new FDA-approved drug is a product of Ariad Pharmaceuticals, Inc., which was acquired by Takeda on Feb. 16, 2017.
Ariad previously studied the potential of brigatnib - Alunbrig's active ingredient - to inhibit ALK+ tumor cells and discovered that the compound proved effective in inhibiting ALK+ tumor cells and its mutations that were resistant to current ALK+ NSCLC medication.
Clinical Trial Results And Possible Side Effects
According to the official report, patients received a once-daily dose of 90mg brigatinib for seven days. If a patient could tolerate the 90mg dose, the dosage is increased to 180mg once daily for seven days.
The Independent Review Committee calculated that the overall response rate for those who were kept at 90mg was at 48 percent while those who received 180mg had an overall response rate of 53 percent. Investigator assessment showed results of 45 percent and 54 percent, respectively.
The most common reactions to the medication that affected more than 25 percent of the patients, according to the report based on clinical trials, were headache, nausea, cough, fatigue, and diarrhea.
Serious adverse reactions to the medication also exhibited in 38 percent of patients in the 90mg group and 40 percent of patients for those whose dosage were increased to 180mg. Reactions include pneumonia and interstitial lung disease pneumonitis.
Unfortunately, there were a few fatal reactions that occurred in 3.7 percent of the patients enrolled in the clinical trials. Two patients succumbed to pneumonia while bacterial meningitis, dyspnea, pulmonary embolism, respiratory failure, urosepsis, and sudden death affected one patient each.
The researchers advise that doctors and patients avoid concomitant use of Alunbrig with strong CYP3A inhibitors, inducers, and substrates.