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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
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 thyroid cancer (TC) with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
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 with advanced RET fusion positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib
Evidence Level:
Sensitive: A1 - Approval
Published date:
12/12/2020
Excerpt:
Retsevmo as monotherapy is indicated for the treatment of adults with...advanced RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib.
Evidence Level:
Sensitive: A1 - Approval
New
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 fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory…
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

ESMO Clinical Practice Guideline update on the use of systemic therapy in advanced thyroid cancer

Published date:
04/28/2022
Excerpt:
Recommendations...selpercatinib is an option to treat adults with advanced/metastatic RET fusion-positive DTCs who have already received MKI therapy with sorafenib, lenvatinib or both…
DOI:
https://doi.org/10.1016/j.annonc.2022.04.009
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 fusion-positive thyroid cancer in adults who need systemic therapy after sorafenib or lenvatinib...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
...Cohorts 1 and 2: enrollment will be restricted to patients with evidence of a RET gene alteration in tumor....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

2229P - Updated safety and efficacy of selpercatinib in patients (pts) with RET-activated thyroid cancer: Data from LIBRETTO-001

Published date:
10/16/2023
Excerpt:
With longer f/u and additional pts, selpercatinib continues to demonstrate very durable responses in pts with RET-fusion thyroid cancer with or without prior therapy, suggesting use of selpercatinib as first systemic therapy appears to be highly effective in treatment of TC. The safety remained tolerable despite longer duration on treatment.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of selpercatinib in Chinese patients with advanced RET-altered thyroid cancers: results from the phase II LIBRETTO-321 study

Published date:
08/29/2022
Excerpt:
Of 77 enrolled patients, 29 had RET-mutant MTC and one had RET fusion-positive TC….In all enrolled MTC patients (n = 29), the ORR by IRC was 58.6% (95% CI, 38.9–76.5). One RET fusion-positive TC patient treated for 23.4 weeks achieved a partial response at week 8 that was ongoing at cutoff....Selpercatinib showed robust antitumor activity and was well tolerated in Chinese patients with advanced RET-altered TC, consistent with global data from LIBRETTO-001.
DOI:
https://doi.org/10.1177/17588359221119318
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
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Efficacy of Selpercatinib in RET-Altered Thyroid Cancers

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 19 patients with previously treated RET fusion–positive thyroid cancer, the percentage who had a response was 79% (95% CI, 54 to 94), and 1-year progression-free survival was 64% (95% CI, 37 to 82).
DOI:
10.1056/NEJMoa2005651
Trial ID: