Pulmonary and thyroid carcinoma: FDA approves the treatment with Retevmo

The Food and Drug Administration (FDA) approved Retevmo (selpercatinib) for three types of cancer treatment that present alteration (changing) in the RET gene (REarranged during Transfection).

 

FDA, approves Retevmo in the “non-small cells” pulmonary carcinoma treatment

In particular, Retevmo has been approved for the treatment of different types of cancer. It can be administered to:

  • diffuse non-small cell lung cancer (NSCLC) in adult patients
  • advanced medullary thyroid cancer (TCM) or TCM that has spread, in patients 12 years of age or older
  • RET fusion-positive advanced thyroid cancer in subjects 12 years of age or older

Retemvo is the first specific therapy approved for cancer with alterations of the RET gene. For Retevmo’s approval, the FDA relied on the results of a clinical trial that involved patients with each of the three types of cancer.

During the clinical trial, patients received Retevmo 160 mg orally twice-a-day until disease progression or -unacceptable toxicity. The overall response rate (ORR), which reflects the percentage of patients who had a certain amount of tumour contraction, and the duration of response (DOR) were taken as the main efficacy outcome measures.

The efficacy in the treatment of NSCLC has been assessed in 105 adult patients with RET-positive fusion NSCLC, previously treated with platinum chemotherapy. The ORR for the 105 patients was 64%.

For 81% of patients who had a response to treatment, the duration was at least six months.

 

FDA and the efficacy of Retevmo

The efficacy of Retemvo was also assessed in 39 patients with RET-positive fusion NSCLC never treated before. For these patients, the ORR was 84%. In 58% of treatment response cases, the duration was at least six months.

Efficacy in the treatment of MTC in adults and pediatric patients was evaluated in 143 patients with advanced or metastatic RET-mutant TCM, previously treated with cabozantinib, vandetanib or both, and in patients with advanced or metastatic RET-mutant TCM who previously they had not received treatment with cabozantinib or vandetanib.

The ORR for the 55 previously treated patients was 69%. For 76% of patients who had a response to treatment, the duration was at least six months.

Efficacy was also assessed in 88 patients who had not previously been treated. The ORR for these patients was 73%. In 61% of treatment response cases, the duration was at least six months.

 

The efficacy of drugs for the Food & Drug Administration (FDA)

The efficacy of Retevmo in the treatment of fusion-positive RET thyroid cancer in adults and pediatric patients aged 12 years and older were evaluated in a study that enrolled 19 patients with fusion-positive RET thyroid cancer who were refractory to radioactive iodine (RAI), if appropriate treatment option, and had previously received another systemic treatment, and 8 patients with fusion-positive RET thyroid carcinoma, refractory to RAI but who had not received any additional therapy.

The ORR, for the 19 previously treated patients, was 79%. In 87% of cases of response to treatment, the duration was at least six months. In the 8 patients who had not received any therapy other than RAI, the ORR was 100%.

In 75% of patients, the response lasted at least six months. The most common side effects of Retevmo were the increase in the enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the liver, increased blood sugar, decreased white blood cell count, decreased albumin in the blood, decreased calcium in the blood, dry mouth, diarrhoea, increased creatinine, increased alkaline phosphatase, hypertension, fatigue, swelling in the body or limbs, low blood platelet count, increased cholesterol, rash, constipation and decreased sodium in the blood.

Among the serious side effects that Retevmo can cause, hepatotoxicity, high blood pressure, prolongation of the QT interval, bleeding and allergic reactions.

Retevmo has received orphan drug designation, Priority Review and Breakthrough Therapy from the FDA and has been approved through the accelerated approval process.

 

Pulmonary and thyroid carcinoma: FDA approves the treatment with Retevmo – READ THE ITALIAN ARTICLE

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