Expanded Indication for Alecensa
November 6, 2017 – The U.S. FDA has approved an expanded indication for Alecensa® (alectinib) capsules, manufactured by Genentech, as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) that is found to be positive for anaplastic lymphoma kinase (ALK) using an FDA-approved diagnostic test. The original FDA approval for Alecensa, granted in 2015, indicated the drug as a second-line therapy, to be used only if treatment with Pfizer’s Xalkori® (crizotinib) became ineffective or was no longer tolerated. However, a subsequent clinical trial found that patients treated with Alecensa had a longer average progression-free survival rate (25.7 months) versus those treated with Xalkori (10.4 months). Recommended dosing with Alecensa is 600mg taken with a meal two times daily. The drug is available in 150mg capsules only.
Liver function should be tested at least once a month in patients taking Alecensa, as there is a risk of hepatotoxicity. Additional precautions, such as creatine phosphokinase (CPK) assessments and regular monitoring of heart rate and blood pressure, should be taken during the course of treatment with Alecensa, due to potential side effects.
ALK-positive non-small cell lung cancer is typically found in non-smoking patients who are in their 30s and 40s, most often affecting women and individuals of Asian descent. According to the American Cancer Society, ALK-positive NSCLC will make up an estimated two to seven percent of new NSCLC cases diagnosed in the U.S. in 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.