The FDA has approved Retevmo capsules for the treatment of patients with lung cancer or thyroid cancer harboring RET alterations. This is the first therapy approved to target RET gene alterations.
Specifically, the approval is for the following indications:
- Adult patients with metastatic RET+ Non–Small Cell Lung Cancer, NSCLC
- Adult and pediatric patients 12 years of age and older with advanced or metastatic RET+ Medullary Thyroid Cancer, MTC
- Patients with advanced or metastatic RET+ thyroid cancer who require systemic therapy and who are radioactive iodine, RAI–refractory, if RAI was appropriate
Retevmo was approved based on positive results from the phase I/II LIBRETTO-001 trial –
In the trial, patients with RET+ received treatment with 160 mg Retvmo orally twice daily.
RET+ Non-Small Cell Lung Cancer, NSCLC, patients’ results
Among the evaluable adult patients with RET+ NSCLC treated in the trial were 105 who had previously received platinum chemotherapy and 39 who were treatment naïve:
- In the previously treated group, 64% experienced disease shrinkage or stabilization, with 81% of these patients maintaining their response for at least 6 months. The median duration of response was 17.5 months.
- In the treatment-naïve group, 84% experienced disease shrinkage or stabilization with 58% of these responses lasting for at least 6 months. The median duration of response was not reached in this subgroup.
- 11 patients who had measurable brain metastases had an experienced shrinkage or stabilization of the lesions in the brain, with 10 of these patients experiencing it for at least 6 months.
- In the clinical trial, metastatic lung cancer patients experienced response to under the treatment with Retevmo, including responses in difficult-to-treat brain metastases
RET+ MTC patients’ results
The MTC subgroup consisted of 143 patients. 55 of these patients had been previously treated with Cabozantinib (Cabometyx), Vandetanib (Caprelsa) or both.
- In the previously treated group, 69% experienced disease shrinkage or stabilization with 76% of these responses lasting for at least 6 months. The median duration of response was not reached.
- In the treatment naïve MTC group, 73% experienced disease shrinkage or stabilization with 61% of these patients maintained their response for at least 6 months. The median duration of response was 22 months.
RET+ thyroid cancer patients’ results
- 27 patients with RET+ thyroid cancer were treated in the study. 19 of these patients were refractory to RAI and had received other prior systemic therapy. In the previously treated group 79% experienced disease shrinkage or stabilization with 87% of responders maintaining a response for at least 6 months. The median duration of response was 18.4 months.
- The other 8 patients with RET+ thyroid cancer were RAI-refractory and had not received additional therapy. 100% experienced disease shrinkage or stabilization with 75% of these patients still in response after at least 6 months. The duration of response was not reached.
Side Effects
Serious side effects possible with Retevmo include hepatotoxicity, elevated blood pressure, QT prolongation, bleeding, and allergic reactions. The FDA noted that in the event of hepatotoxicity, the dose of Retevmo should be reduced, interrupted or discontinued permanently. The FDA also cautioned regarding treatment with Retevmo when undergoing surgery and in pregnant and breastfeeding women.
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