FDA Grants Genotech Accelerated Approval for Alecensa
December 14, 2015 - The U.S. Food and Drug Administration granted Genotech accelerated approval for Alecensa (alectinib). Alecensa is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic Non-Small Cell Lung Cancer (NSCLC) who have progressed on, or are intolerant to, crizotinib (Xalkori –Pfizer). The recommended dose for Alecensa is 600mg, to be taken twice daily with food. Alecensa will be available through a limited network of specialty pharmacies.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.