Two FDA approvals for immunotherapy for NSCLC

In October 2015 FDA approves two immunotherapys nivolumab (Opdivo) and pembrolizumab (Keytruda) for non small cell lung cancer.

While not targeted at ALK they are new treatments they could be tried by an ALK+ lung cancer patient, especially if their tumors tested positive for PD-L1. Both drugs cost $150,000 a year.

For Opdivo, patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo.

For Keytruda, patients must have a PD-L1 expression tumor proportion score (TPS) of greater than or equal to 50% tumor cells. If appropriate, targeted therapy for ALK or EGFR mutations must have been tried.

Both FDA approvals require prior treatment with chemotherapy and as applicable an ALK inhibitor.

My layman’ understanding is that while the duration of response to these drugs is notably longer for those patients who respond, that the overall response rate for these drugs is closer to 20% than the 50% – 70% rates for targeted therapies and the 80% plus rates when stabilization rates are included.

http://www.wsj.com/articles/fda-approves-mercks-keytruda-for-most-common-form-of-lung-cancer-1443810117

http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm

This entry was posted in Imunotherapies, Lung cancer, Potential Treatments, Regulatory applications & approvals. Bookmark the permalink.

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