Regulators will decide by late fall whether to approve a cancer drug designed to a target genetic abnormality in tumors regardless of where in the body the tumor occurs.
Loxo Oncology said Tuesday that the Food and Drug Administration had accepted its approval application for LOXO-101, also known as larotrectinib, in adults and children whose cancers display genetic alterations known as NTRK fusions. The agency has given the application priority review and will decide on approval by Nov. 26.
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If approved, larotrectinib would be the second drug to win a biomarker-based label, following the approval last may of Merck & Co.’s Keytruda for cancers that display abnormalities known as microsatellite instability-high (MSI-H) and mismatch repair deficiency (dMMR). On Thursday, Merck and diagnostics maker Foundation Medicine announced a collaboration to develop companion diagnostics to detect MSI-H and dMMR in tumors using Foundation’s next-generation sequencing technology.
Development of drugs with biomarker-driven labels remains in the early stages, but it has been picking up in recent years. A recent report by Trinity Partners identified two drugs – namely larotrectinib itself and another NTRK inhibitor, Ignyta’s RXDX-101 (entrectinib) – in registration-directed clinical trials, along with a further nine in potentially registrational studies. The remaining 26 were in exploratory trials. The drugs are being developed in “basket” studies that enroll patients based on whether they display the genetic abnormalities rather than based on having specific tumor types.
Loxo is also developing another NTRK inhibitor, LOXO-195, and a RET inhibitor, LOXO-292. Ignyta was acquired by Swiss drug maker Roche in February. Loxo’s shares rose 20 percent on May 18 in response to an abstract of LOXO-292 data from the upcoming American Society of Clinical Oncology meeting. However, the company’s stock was mostly flat Tuesday morning following the LOXO-101 announcement. The ASCO meeting kicks off Friday at Chicago’s McCormick Place.
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