The European Medicines Agency (EMA, by its seal in English) has authorized the commercialization of Selpercatinib (Retsevmo) for the treatment of pulmonary cancer in advanced microcytic (CPNM) y advanced thyroid cancer, in both cases with merger of gen RET positive, y advanced thyroid cancer with mutation of the RET gene, which requires a systematic treatment.
The mergers in RET are already in the pipeline 2% of CPNM tumors and between 10-20% of cases with papillary thyroid cancer. The mutations in RET represent the 60% of thyroid medullary cancer (CTM) sporadic and the 90% of these tumors CTM kiem.
While respecting thyroid cancer, Enrique Grande, Jefe of the Oncology Medical Service MDAnderson Cancer Center in Madrid, joins GACETA MÉDICA, as the issue of this treatment is “the opportunity to offer a new precision medicine” and “a radical change and treatment”.
Selpercatinib is indicated for patients with thyroid tumors, well with mutation or fusion of the RET gene, in both cases hooi metastasis from a primary tumor and is not controlled with habitats.
In thyroid cancer, there are three types of histologies: thyroid differences, thyroid medullary —Que apenas representan 4-8 por ciento— y thyroid anaplasia —Que suelen ser entre el 2-3 por ciento—. Thus, 90 per cent of cases have differentiated tumors of thyroid.
Hasta now, patients with thyroid cancer or thyroid cancer are treated with tyrosine quinase inhibitors dirigidos to avoid angiogenesis and act upon other receptors on the membrane of tumor cells ”Signal Grande. In thyroid anaplasia, tumors with the most devastating thyroid cancer prognosis, “current treatments are based on classic chemotherapy but the hope of life oscillates between 4 and 6 months when the tumor has metastasized ”, added.
The conditional authorization for commercialization for selpercatinib is supported by the results of the extended efficiencies during the trial of phases 1/2 LIBRETTO-001, the mayor of clinical practice conducted until patients with tumors with alterations in the gen RET.
“When to administer selpercatinib as the only medication in patients that has a mutation that affects the RET gene or a fusion that affects the RET gene, has been observed a significant reduction in the rate of metastasis approximately 70 per patient“, Resalta el experto.
Assimilation, in patients with very voluminous disease, “the reduction of tumor size includes a level of tumors used for the tumor. For so, no solemnity is activity, we increase the quality of life of the patient with thyroid cancer ”, the oncologist points out.
Ensayo phases 1/2 LIBRETTO-001
In the same case, naïve patients participate (no pre-treatment) and patients who have received pre-treatment many treatments with a variety of advanced solid tumors, such as CPNM with positive fusion in the RET gene, the CTM with mutations in the RET gene, Positive fusion in the RET gene and other solid tumors with alterations in the RET gene.
In the case of CPNM with positive fusion in the RET gene was evaluated in 105 adult patients treated with platinum chemotherapy and 39 patients who had not received systemic treatment. Patients treated with anterior anterior TRO of 64% with a median response time of 17.5 months.
In the case of CPNM with positive fusion in the RET gene and metastasis in the central nervous system (Independently of the analyzed condition), the objective response rate in evaluative patients was 87% with a median response time of 9.36 months.
In relation to the efficacy of selpercatinib in CT with positive fusion in the RET gene, was studied in 19 patients treated predominantly with sorafenib and / or lenvatinib and 8 patients who did not receive treatment with anteriority. The TRO for the 19 patients treated was prevalent at 79% with a median response time of 18.4 months.
Finally, in the group of patients with CTM with mutations in the RET gene 55 patients were treated primarily with cabozantinib, vandetanib or both. The TRO for these patients is 69% with a median duration of response of no more than 17.5 months.