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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Title:

The China NMPA Approves Selpercatinib for the Treatment of Patients with RET-driven Lung and Thyroid Cancers

Published date:
10/09/2022
Excerpt:
Innovent Biologics, Inc...is pleased to see that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for selpercatinib (40mg & 80mg capsules) for...adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy...
Evidence Level:
Sensitive: A1 - Approval
Title:

RET targeted therapies Retevmo, Gavreto to compete in Korea

Published date:
03/11/2022
Excerpt:
On March 11, the Ministry of Food and Drug Safety authorized the use of Lilly’s Retevmo in adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer requiring systemic therapy...The approval for Retevmo was based on the LIBRETTO-001 trial in RET-mutated advanced or metastatic solid cancer patients.
Evidence Level:
Sensitive: A1 - Approval
Title:

UK conditionally approves Lilly’s Retsevmo® for RET-driven lung and thyroid cancers

Published date:
03/12/2021
Excerpt:
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for Retsevmo® (selpercatinib) as monotherapy for several RET-driven advanced lung and thyroid cancers....The treatment was approved for...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.
Evidence Level:
Sensitive: A1 - Approval
Published date:
12/12/2020
Excerpt:
Retsevmo as monotherapy is indicated for 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.
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
RETEVMO is a kinase inhibitor indicated for the treatment of...Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Selpercatinib for treating advanced thyroid cancer with RET alterations

Published date:
10/01/2021
Excerpt:
Selpercatinib is recommended for use within the Cancer Drugs Fund, as an option for treating...advanced RET-mutant medullary thyroid cancer in people 12 years and older who need systemic therapy after cabozantinib or vandetanib…
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
Medullary Thyroid Cancer: Preferred regimens…Selpercatinib (RET mutation-positive)
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

Phase 1/2 Study of LOXO-292 in Patients With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

Excerpt:
...Identity of RET gene fusions, mutations, and concurrently activated oncogenic pathways in tumor biopsies and cfDNA. Cohorts 1 and 2: enrollment will be restricted to patients with evidence of a RET gene alteration in tumor...MTC syndrome spectrum cancers (e.g., MTC, pheochromocytoma), cancers with neuroendocrine features/differentiation, or poorly differentiated thyroid cancers with other RET alteration/activation may be allowed with prior Sponsor approval...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1656P - Durable efficacy of selpercatinib in patients (pts) with medullary thyroid cancer (MTC): Update of the LIBRETTO-001 trial

Published date:
09/05/2022
Excerpt:
With longer f/u and additional pts, selpercatinib continues to demonstrate very durable responses in MTC patients with or without prior cab/van therapy, suggesting first line use of selpercatinib appears to be highly effective in treatment of MTC. The safety profile is unchanged despite longer duration on treatment.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Treatment outcome with a selective RET tyrosine kinase inhibitor selpercatinib in children with multiple endocrine neoplasia type 2 and advanced medullary thyroid carcinoma

Published date:
10/11/2021
Excerpt:
Medullary thyroid carcinoma (MTC) in the context of multiple endocrine neoplasia type 2 (MEN2) is caused by mutations in the RET proto-oncogene...The fall in serum calcitonin was evident within 2 weeks of the start of selpercatinib, and responses were ongoing at a median follow-up of 13 months (range, 11-22 months).... Selpercatinib has shown excellent therapeutic efficacy with minimal toxicity in children with MEN2 and progressive metastatic RET-mutated MTC.
DOI:
10.1016/j.ejca.2021.09.012
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy of selpercatinib after prior systemic therapy in patients with RET mutant medullary thyroid cancer.

Published date:
05/19/2021
Excerpt:
The ORR on selpercatinib (69%) was markedly higher than for the last prior therapy (10%) received before enrollment. ORR improvements with selpercatinib were observed regardless of prior therapy...Prior to selpercatinib, response with previous multikinase therapy was rare. By contrast, selpercatinib demonstrated robust efficacy regardless of response to or specific prior therapy in pts with RET mutant MTC.
DOI:
10.1200/JCO.2021.39.15_suppl.6074
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Selpercatinib efficacy and safety in patients with RET-altered thyroid cancer: A clinical trial update.

Published date:
05/19/2021
Excerpt:
Patients (pts) with RET-mutant medullary thyroid cancer (MTC) and RET-fusion positive thyroid cancer (TC) were enrolled...In this updated analysis, selpercatinib continued to show marked and durable antitumor activity in pts with RET-altered thyroid cancers. Selpercatinib was well tolerated and no new safety concerns were identified.
DOI:
10.1200/JCO.2021.39.15_suppl.6073
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Matching Adjusted Indirect Comparison (MAIC) in RET-Mutation Positive Medullary Thyroid Cancer (MTC)

Published date:
04/12/2021
Excerpt:
...selpercatinib demonstrated a significant improvement in PFS and OS versus cabozatinib and versus placebo...The selpercatinib OS HR was 0.25 (95% CI:0.12,0.54; p=0.002) and 0.11 (95% CI:0.05,0.24;p<0.001) versus cabozantinib and placebo...PFS curve data were available for the RET-positive cohort but OS was only provided forthe RET M918T subgroup...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy of Selpercatinib in RET-Altered Thyroid Cancers

Published date:
08/27/2020
Excerpt:
In the first 55 consecutively enrolled patients with RET-mutant medullary thyroid cancer...In this phase 1-2 trial, selpercatinib showed durable efficacy with mainly low-grade toxic effects in patients with medullary thyroid cancer with and without previous vandetanib or cabozantinib treatment.
DOI:
10.1056/NEJMoa2005651
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy of Selpercatinib in RET-Altered Thyroid Cancers

Published date:
08/27/2020
Excerpt:
We enrolled patients with RET-mutant medullary thyroid cancer with or without previous vandetanib or cabozantinib treatment, as well as those with previously treated RET fusion-positive thyroid cancer, in a phase 1-2 trial of selpercatinib….In this phase 1-2 trial, selpercatinib showed durable efficacy...
DOI:
10.1056/NEJMoa2005651
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Selpercatinib (LOXO-292) in patients with RET-mutant medullary thyroid cancer.

Published date:
05/13/2020
Excerpt:
Selpercatinib use was associated with marked and durable antitumor activity in prior cabozantinib and/or vandetanib-treated patients and in cabozantinib/vandetanib-naïve patients with RET-mutant MTC…
DOI:
10.1200/JCO.2020.38.15_suppl.3594
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A phase 1 study of LOXO-292, a potent and highly selective RET inhibitor, in patients with RET-altered cancers.

Excerpt:
...RET fusion+ NSCLC and papillary thyroid cancer (PTC), RET-mutant medullary thyroid cancer (MTC)...Tumor reduction was achieved in 79% of MTC pts…
DOI:
10.1200/JCO.2018.36.15_suppl.102
Trial ID:
Evidence Level:
Sensitive: C4 – Case Studies
Source:
Title:

Neoadjuvant selpercatinib for advanced medullary thyroid cancer

Published date:
11/09/2020
Excerpt:
Herein, we report a case of a patient with initially unresectable, widely metastatic, RET‐mutated medullary thyroid carcinoma treated on a single‐patient clinical protocol with neoadjuvant selpercatinib/LOXO‐292 followed by definitive surgery. The significant tumor response to neoadjuvant selpercatinib rendered his locoregional disease resectable, and he is now 21 months postinitiation of neoadjuvant treatment with stable distant disease (following partial response) on continued therapy.
DOI:
10.1002/hed.26527