Alunbrig Approved for Non-Small Cell Lung Cancer
April 28, 2017 – The U.S. FDA provided accelerated approval for Alunbrig™ (brigatinib), manufactured by Takeda Oncology. Alunbrig, an oral tyrosine kinase inhibitor (TKI), is indicated for the treatment of patients who have metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC), and who have progressed on or are intolerant to Xalkori® (crizotinib – Pfizer/EMD Serono). Recommended dosing is 90mg per day for one week, followed by 180mg per day if the patient can tolerate the higher dose.
Alunbrig will be available through a limited network of specialty pharmacies by mid-May.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.