Shooting Cancer Highlights – Periodic focus on regulatory status of new targeted therapies in oncology

EMA

September 22 – Vorasidenib – LGG IDH1/2. The European Commission (EC) has approved the first-in-class dual isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma (subtypes of low-grade glioma, [LGG]) with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and who are not in immediate need of radiotherapy or chemotherapy. 

FDA

September 25 – Imlunestrant – BC ESR1. The U.S. Food and Drug Administration (FDA) has approved the oral selective estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET).

September 3 – Zongertinib – NSCLC HER2. The HER2 tyrosine kinase inhibitor has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations.

Zongertinib was approved last month by the FDA for adult patients with unresectable or metastatic non-squamous NSCLC whose tumours have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations and who have received prior systemic therapy.

September 4 – Olomorasib – NSCLC KRAS. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the second-generation inhibitor of KRAS G12C with preliminary evidence of central nervous system activity, in combination with pembrolizumab, for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ? 50%, as determined by FDA approved tests.