FDA conditionally approves Loralatinib

As of 11-2-2018 the FDA conditionally approved Loralatinib. It’s brand name is Lorbrena.

The approval is for Loralatinib treatment for patients: 1) as a third line after crizotinib and one other ALK inhibitor (basically Brigatinib), or 2) as a second line treatment after either: A) Alectinib, or B) Ceritinib.

At this time Brigatinib has not been approved as a first line treatment 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. A description is posted on March 1, 2019 on this site.



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

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