Less than 2 weeks after getting FDA approval for a rare form of lung cancer, Alunbrig (brigatinib) is now available via Biologics, a special oncology pharmacy division of McKesson Specialty Health.
On April 29th
, the kinase inhibitor developed by Takeda was approved for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Brigatinib can be taken orally. The recommended dose is 90 mg once daily for the first 7 days. If 90 mg is tolerated during the first 7 days, patients should increase the dose to 180 mg once daily. The pill can be taken with or without food.
The drug received an Accelerated Approval based on tumor response rate and duration of response. An Accelerated Approval means Takeda can market the drug now but additional studies (ie, a phase 3 clinical trial) may be needed by the FDA moving forward.
The FDA approval was based largely on the Phase 2 ALTA (A
LK in L
ung Cancer T
rial of A
P26113) trial of brigatinib in adults. This ongoing, two-arm, open-label, multicenter trial enrolled 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib.
With a median follow-up of 8 months, 53% of patients who received the recommended dosing regimen (90→180 mg) achieved a confirmed overall response (OR with a median duration of response of 13.8.
The drug was also effective in patients who had their cancer metastasized to the brain. At the recommended dosing regimen, 67% of patients with measurable brain metastases (n=18) achieved a confirmed intracranial OR by IRC.
At the recommended dosing regimen, the most common adverse reactions (≥25%) are nausea, diarrhea, fatigue, cough, and headache.
The drug comes with warnings and precautions
. The drug has been associated with interstitial lung disease (ILD)/pneumonitis, hypertension, bradycardia, visual disturbance, creatine phosphokinase (CPK) elevation, pancreatic enzyme elevation, hyperglycemia and embryo-fetal toxicity. Please see the prescribing information
for further details.
Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.
About ALK+ NSCLC
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer is not considered a rare cancer. However, approximately 2 – 8% of patients with NSCLC have a rearrangement in the ALK gene.
About 70% patients with ALK+ NSCLC who progress following first-line ALK inhibitor therapy develop brain metastases.