EMA

  • January 9 – sotorasib-NSCLC KRAS G12C: the European Commission has granted conditional marketing authorization for the treatment of adult patients with advanced NSCLC with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.
  • January 28 – lorlatinib – NSCLC ALK Fusions: the European Commission granted marketing authorization as monotherapy for the first-line treatment of adult patients with ALK-Positive advanced NSCLC, previously not treated with an ALK inhibitor.

FDA

  • January 25 – tebentafusp – UM HLA-A*02:01: FDA approved the drug for the treatment of adult patients with HLA-A*02:01-positive metastatic uveal melanoma.
  • January 17 – trastuzumab deruxtecan – BC HER2+: FDA granted Priority Review for the treatment of adult patients with unresectable or metastatic HER2+ breast cancer, who have received a prior anti-HER2-based therapy.
  • January 10 – enobosarm – BC AR+/ER+/HER2-: FDA granted Fast Track Designation for the treatment of patients with AR+/ER+/HER2- metastatic breast cancer. Patients eligible for this treatment have disease progressed following therapy with a non-steroidal aromatase inhibitor, fulvestrant, and a CDK4 / 6 inhibitor, and an AR nucleus staining of 40% or higher.
  • January 18 – gedatolisib – BC HR+/HER2-: FDA granted Fast Track Designation for the treatment of patients with HR+/HER2- metastatic breast cancer, who have progressed on CDK4/6 inhibitor therapy and endocrine therapy.
  • January 18 – CYNK-101 – G/GEJC HER2+: FDA granted Fast Track Designation for the treatment of patients with advanced HER2+ gastric or gastroesophageal junction cancer, in combination with standard frontline chemotherapy, trastuzumab and pembrolizumab.
  • January 24 – Pidnarulex – BC OA BRCA1/2 PALB2 HRD mutations: FDA granted Fast Track Designation for the treatment of patients with breast and ovarian cancers, that harbor BRCA1/2, PALB2 or other homologous recombination deficiency (HRD) mutations.
  • December 23 – Patritumab deruxtecan – NSCLC EGFR mutations: FDA granted Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor (TKI) and platinum-based therapies.
  • December 23 – Patritumab deruxtecan – NSCLC EGFR mutations: FDA granted Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor (TKI) and platinum-based therapies.
  • January 4 – CLN-081 – NSCLC EGFR ex20ins: FDA granted Breakthrough Therapy Designation for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 mutations that has previously been treated with a systemic platinum-based chemotherapy.
  • January 4 – Telisotuzumab vedotin – NSCLC EGFR WT/c-MET overexpression: FDA granted Breakthrough Therapy Designation for the treatment of patients with advanced or metastatic EGFR wild-type NSCLC with high levels of c-Met overexpression who have progressed on a platinum-based therapy.
  • January 5 – Tiragolumab – NSCLC EGFR/ALK WT PD-L1: FDA granted Breakthrough Therapy Designation for the first-line treatment of adult patients with metastatic NSCLC whose tumours have high PD-L1 expression with no EGFR or ALK genomic aberrations, in combination with atezolizumab.
  • January 27 – Sunvozertinib – NSCLC EGFR ex20ins: FDA granted Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.