FDA conditionally approves Loralatinib

As of 11-2-2018 the FDA conditionally approved Loralatinib.

The approval is for Loralatinib treatment for patients who have already received either: 1) crizotinib and one other ALK inhibitor, or 2) as first line treatment only either: A) Alectinib, or B) Ceritinib.

At this time Brigatinib as a first line treatment has not been approved by The FDA. Although a positive Phase 3 trial results were recently published.

The FDA approval is conditioned on a Phase 3 trial being completed.

https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_lorbrena_lorlatinib_for_previously_treated_alk_positive_metastatic_nsclc

 

This entry was posted in 3922 - lorlatinib by Pfizer, alectinib - Alecensa from Chugai - Roche - GenenTech, AP26113 - brigatinib from Ariad, Brain metastases, ceritinib - Zykadia from Novartis, crizotinib - Xalkori from Pfizer, Lung cancer, Potential Treatments, Regulatory applications & approvals. Bookmark the permalink.

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