Posted from: Sunday, December 11, 2016 - 04:31 PM - Present

New Indication for Keytruda

October 24, 2016 - The US FDA approved Keytruda® (pembrolizumab), manufactured by Merck. Keytruda’s new indication is for  the initial therapy of metastatic non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, but expressing 50% or more of programmed death ligand 1 (PD-L1). The presence of PD-L1 must be verified by an FDA-approved diagnostic test. At this same time new labeling was announced and additional information was added from studies of patients who have metastatic NSCLC that produces at least 1% of PD-L1 and that advances despite treatment with chemotherapy regimens containing platinum. For NSCLC, 200mg of Keytruda is given once every three weeks as a 30-minute IV infusion. Previous approvals for Keytruda include melanoma and head and neck cancers.

 

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.

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Last Updated Saturday, March 25, 2017 - 02:58 AM.