The
The treatment was approved for:
- the treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy
- the treatment of adults with advanced RET fusion positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib
- the treatment of adults and adolescents 12 years and older with advanced RET mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with cabozantinib and/or vandetanib.
Lung cancer is the third most common cancer, with roughly 85,000 people in the
Additionally, there are around 3,700 new thyroid cancer cases in the
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The treatment was granted authorisation based on the LIBRETTO-001 Phase I/II trial’s endpoints of objective response rate (ORR) and duration of response (DoR). In the trial, selpercatinib was evaluated in a single-arm of over 700 of patients with RET-driven cancers. In the primary analysis of 105 previously treated patients with NSCLC, 64 percent responded to treatment with an average DoR of 17.5 months. In the previously treated RET-mutant medullary thyroid cancer patients, primary analysis of 55 patients had a 69.1 percent response rate.
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The most common serious adverse drug reactions (ADRs) are hypertension (0.9 percent), increased aspartate aminotransferase (AST) (1.6 percent) and increased alanine aminotransferase (ALT) (1.6 percent). Permanent discontinuation of selpercatinib for treatment emergent adverse events, regardless of attribution occurred in six percent of patients. ADRs resulting in permanent discontinuation by two or more patients included increased ALT, increased AST, hypersensitivity and thrombocytopenia.
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