Loxo Oncology To Seek FDA Approval Of Larotrectinib After Positive Response

Loxo oncology has revealed that it will be seeking approval from the Food and Drug Administration for its larotrectinib drug. The drug is aimed at treating patient suffering from TRK tumors that are fusion positive. This follows a study which showed that about 75% of the participants had responded positively to the drug. If it gets the approval of the FDA, larotrectinib will be offered to patients dependent on their specific genome characteristics. With larotrectinib it does not matter which part of the body the tumors occur in.

During an American Society of Clinical Oncology meeting, the largest gathering of cancer doctors in the United States, Memorial Sloan Kettering Cancer Center’s David Hyman participated in a discussion revolving around the trials where 55 patients, both adults and minors participated. The pediatric patients who took part in the study were suffering from infantile fibrosarcoma as well as other types of thyroid cancers and sarcomas. The adult patients on the other hand were suffering from various tumor types including sarcomas, thyroid, melanoma, pancreatic, biliary, colon, breast and lung cancers.

Cancer types

There were about 17 cancer types involved in the study and the results show that 76% responded to the drug. Among the 76%, 12% had their tumors completely disappear while another 64% had their tumors shrink partially.

Out of the parties who had a complete response, two are in a position to undergo surgery that could potentially cure them, according to Hyman. After half a year of treatment, 91% of patients who responded positively were able to remain progression free.

High tolerance

Among the patients who failed to respond, in about 50% the disease remained stable while in the other half, the disease progressed. Tolerance for the drug was high and only about 13% of the patients required to have their dose modified. There were also no cases where patients had to drop out of the study as a result of toxicities.

“I believe these data demonstrate that larotrectinib is consistently and durably effective in TRK fusion-positive cancers regardless of tumor type,” Hyman concluded.

For the past 18 months Loxo has been involved in discussions with the Food and Drug Administration and a decision could be made by the regulator on whether to approve the drug by June next year. TRK fusions happen in about 1% and 3% of patients suffering from cancer every year. In cancers that commonly occur, the TRK fusions are less frequent.