On May 9, 2020, the U.S. Food and Drug Administration (FDA) approved Lilly's relevmo (selpercatinib, loxo-292) capsule for the treatment of non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancer patients, whose tumors had RET mutation or fusion. Retevmo is the first approved treatment specifically for cancer patients with RET gene changes, developed by Loxo oncology, Inc., a subsidiary of Lilly. In early 2019, Lilly acquired Loxo for us $8 billion.
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Richard pazdur, MD, director of the FDA cancer center of excellence and acting director of the cancer disease Office of the center for drug evaluation and research, said: "the innovation of gene specific therapy continues to rapidly promote medical practice and provides patients with previously difficult choices. FDA is committed to reviewing retevmo like therapies for specific subpopulations of cancer patients. "
Specifically, retevmo's approved cancer treatments include:
Adult patients with non-small cell lung cancer (NSCLC)
Local and diffused advanced medullary thyroid carcinoma (MTC) patients aged 12 and over who need systemic treatment
Patients aged 12 years and over with advanced RET fusion positive thyroid cancer who need systemic therapy have stopped responding to radioiodine therapy or are not suitable for radioiodine therapy
As a kinase inhibitor, retevmo blocks the kinase and helps to prevent the growth of cancer cells. Before treatment, laboratory tests must be used to determine RET gene changes in patients.
FDA approval of retevmo is based on the results of a clinical trial involving patients with three types of tumors. During the clinical trial, patients took orally 160 mg retevmo twice a day until the disease progressed or intolerable toxicity occurred. The primary efficacy endpoint was the overall response rate (ORR), which reflected the percentage of patients with tumor reduction and the duration of response (DOR).
Retevmo was evaluated in 105 adult patients with RET fusion positive NSCLC who had received platinum chemotherapy. The orr of 105 patients was 64%. Of the patients who responded to the treatment, 81% responded for at least six months. The efficacy of 39 patients with RET fusion positive NSCLC who had never been treated was also evaluated. The orr of these patients was 84%. Of the patients who responded to the treatment, 58% responded for at least six months.
The effect of retevmo on MTC was evaluated in patients aged 12 and over with RET mutant MTC. In this study, 143 patients with late or metastatic RET mutation MTC who had previously received cabozantinib, vandetanib or both drugs were recruited, as well as those with late or metastatic RET mutation MTC who had not received cabozantini or vandetanib. The orr of 55 patients who were previously treated was 69%. 76% of the patients who responded to the treatment responded for at least six months. The trial also evaluated the efficacy of 88 patients who had not previously received MTC approved treatment. The orr of these patients was 73%. 61% of the patients who responded to the treatment responded for at least six months.
The effect of retevmo on RET fusion positive thyroid cancer was evaluated in adults and pediatric patients over 12 years of age. In this study, 19 patients with radioiodine (RAI) refractory RET fusion positive thyroid cancer who received another previous systemic treatment and 8 patients with Rai refractory RET fusion positive thyroid cancer who did not receive any other treatment were enrolled. The orr of 19 patients who had previously been treated was 79%. 87% responded to the treatment for at least six months. The trial also evaluated the efficacy of 8 patients who did not receive any treatment except rai. The orr of these patients was 100%. 75% of the patients who responded to the treatment responded for at least six months.
Retevmo has been awarded with four incentives, including accelerated approval, priority review, breakthrough therapy, orphan drug qualification, and FDA review.