RETSEVMO (selpercatinib) - Non-small cell lung cancer (NSCLC)

The Committee deems that the clinical benefit of RETSEVMO (selpercatinib) 40 mg and 80 mg, hard capsules, is substantial for the indication “as monotherapy for the treatment of adults with advanced RET (REarranged during Transfection) fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor and as a first-line treatment”.

As first-line treatment

In view of:

• the statistically significant superiority of RETSEVMO (selpercatinib) in terms of progression-free survival assessed by an independent review committee, in a randomised, open-label phase III study in relation to chemotherapy and immunotherapy (LIBRETTO-431),

despite:

• the lack of evidence of an effect on overall survival in the interim analysis, in a context of advanced-stage disease with an unfavourable prognosis;
• the lack of formal conclusion that can be drawn from the quality-of-life findings;
• the safety profile of RETSEVMO (selpercatinib) particularly marked by a greater number in the selpercatinib group than in the control group of grade ≥ 3 AEs (70.3% versus1%), SAEs (34.8% versus 23.5%) and AE-related deaths (4.4% versus 0.0%), as well as cardiotoxicity (in particular grade ≥ 3 arterial hypertension (20.3% versus 3.1%)) observed in the LIBRETTO-431 study and grade ≥ 3 QT prolongation (8.9% versus 0.0% ), AEs mentioned in the SPC and the subject of an RMP;

the Committee deems that RETSEVMO (selpercatinib) provides minor clinical added value (CAV IV) in relation to immunochemotherapy treatment as a first-line treatment.