In the first week of 2019, besides the BMS-Celgene merger, the $8 billion acquisition of Loxo Oncology by Eli Lilly is the largest deal announced.
For a premium of 68%, what is special with Loxo?
Its approval of Vitrakvi in Nov 2018 is definitely a remarkable one, marking the second approval by the FDA based on a patient’s tumor’s molecular information (TRK fusion), regardless of the location of the tumor within the body. (pancan)
That has been the trend since targeted therapies were proved to be extraordinarily effective in certain types of cancer, usually characterized by gene mutations. EGFR is probably the most famous one.
But FDA approvals were still linked to the tumor locations until May 2017 when Merck’s Keytruda was approved upon a biomarker – microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
Before Keytruda became the first cancer treatment for any solid tumor with a specific genetic feature, it had been approved for the treatment of certain patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.
Loxo’s Vitrakvi, however, received its approval solely based on biomarkers since the beginning. Also, Vitrakvi is the first targeted therapy to be approved this way.
And this big step forward for precision medicine is now acquired by Eli Lilly.
