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).

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

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.

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…

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…

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...

...Cohorts 1 and 2: enrollment will be restricted to patients with evidence of a RET gene alteration in tumor....

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.

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.

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.

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).