New Strength of Alunbrig Approved
October 2, 2017 – The U.S. FDA has approved a new 180mg strength of Alunbrig® (brigatinib) tablets, manufactured by Takeda Pharmaceutical and indicated to treat anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) that is refractory or resistant to Xalkori® (crizotinib), manufactured by Pfizer/EMD Serono.
Originally available in 30mg and 90mg tablets, Alunbrig has a recommended dosing of 90mg per day for the first week. An increased dose of 180mg per day is recommended following the first week if patients tolerate the lower starting dose. The new 180mg tablets are anticipated to help these patients better adhere to their treatment schedule by reducing the number of tablets they have to take.
The newly approved 180mg tablets are anticipated to be launched by the end of 2017.
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 1-800-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.