What Conditions is Selpercatinib Indicated For?

What Conditions is Selpercatinib Indicated For?

RET-Positive Advanced Non-Small Cell Lung Cancer

Selpercatinib is indicated for the treatment of patients with RET-positive locally advanced or metastatic non-small cell lung cancer. In a large clinical trial of patients with RET-positive advanced non-small cell lung cancer, among 69 patients who had not received any prior cancer treatment, 84% achieved an objective response (tumor shrinkage of at least 30%), with a median duration of response of 20.2 months. Among 247 patients who had previously received platinum-based chemotherapy or other treatments, the objective response rate was 61%, and the median duration of response was 28.6 months. Additionally, selpercatinib demonstrated robust intracranial activity in patients with brain metastases: 4 out of 5 treatment-naïve patients experienced significant shrinkage or disappearance of brain tumors, and 14 out of 16 previously treated patients achieved similar results.

RET-Positive Advanced Thyroid Cancer

Selpercatinib is also approved for RET-positive advanced thyroid cancer, including medullary and papillary thyroid cancer. Among patients with medullary thyroid cancer, 55 patients who had previously received cabozantinib and/or vandetanib achieved an objective response rate of 76%, with a median duration of response of 45.3 months; while 88 patients who had not received these standard treatments achieved an objective response rate of 81%, with the median duration of response not yet reached. For other types of RET-positive thyroid cancer, 41 patients who had previously received radioactive iodine and systemic therapy achieved an objective response rate of 85%, with a median duration of response of 26.7 months; among 24 patients who had not received prior systemic therapy, the objective response rate was 96%.

Other RET-Positive Advanced Cancers

Beyond lung and thyroid cancers, selpercatinib is also approved for certain other RET-positive advanced solid tumors, such as pancreatic cancer, colon cancer, and breast cancer. In a clinical trial that included 41 such patients, 44% achieved an objective response (tumor shrinkage of at least 30%), with a median duration of response of 24.5 months. This indication was granted accelerated approval based on response rate and duration of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.