{"id":28377,"date":"2022-09-29T07:00:00","date_gmt":"2022-09-29T07:00:00","guid":{"rendered":"http:\/\/f47c68dd07c74433f35d77f28f1af6ac"},"modified":"2024-11-03T15:13:14","modified_gmt":"2024-11-03T15:13:14","slug":"fda-approves-selpercatinib-for-locally-advanced-or-metastatic-ret-fusion-positive-nsclc","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-selpercatinib-for-locally-advanced-or-metastatic-ret-fusion-positive-nsclc\/","title":{"rendered":"FDA Approves Selpercatinib for Locally Advanced or Metastatic RET Fusion-Positive NSCLC"},"content":{"rendered":"

On 21 September 2022, the US Food and Drug Administration (FDA) granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET<\/em>) gene fusion, as detected by an FDA-approved test.<\/p>\n

FDA also approved the Oncomine Dx Target (ODxT) Test (Thermo Fisher Scientific) as a companion diagnostic for selpercatinib.<\/p>\n

Selpercatinib was previously granted accelerated approval for the NSCLC indication on 8 May 2020, based on initial overall response rate (ORR) and duration of response (DoR) in 144 patients enrolled in the LIBRETTO-001 (NCT03157128), a multicentre, open-label, multi-cohort study. The conversion to regular approval was based on data from an additional 172 patients and 18 months of additional follow-up to assess durability of response.<\/p>\n

Efficacy was demonstrated in total of 316 patients with locally advanced or metastatic RET <\/em>fusion-positive NSCLC. Patients received selpercatinib until disease progression or unacceptable toxicity.<\/p>\n

The primary efficacy measures were ORR and DoR as determined by a Blinded Independent Review Committee. Among 69 treatment-na\u00efve patients, ORR was 84% (95% confidence interval [CI] 73, 92) with a DoR of 20.2 months (95% CI 13, not estimable). Among 247 patients previously treated with platinum-based chemotherapy, ORR was 61% (95% CI 55, 67) with a DoR of 28.6 months (95% CI 20, not estimable).<\/p>\n

The median age of patients was 61 years (range 23 to 92). Selected demographics were as follows: 58% female; 49% White, 41% Asian and 5% Black; 97% had ECOG performance status 0 or 1; 97% had metastatic disease. Previously treated patients received a median of two prior systemic therapies (range, 1 to 15); 58% had received prior anti PD1\/PD-L1 therapy.<\/p>\n

The most common adverse reactions (\u226525%) in patients were oedema, diarrhoea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.<\/p>\n

The recommended selpercatinib dose based on body weight is:<\/p>\n