EMA

  • August 22 – Amivantamab – NSCLC EGFR. The European Commission (EC) has approved an extension of indication for the anti-EGFR-MET bispecific antibody in combination with carboplatin and pemetrexed, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 19 deletions (ex19del) or Exon 21 L858R substitution (L858R) mutations, after failure of prior therapy including a third-generation EGFR tyrosine kinase inhibitor (TKI).

FDA

  • September 19 – Amivantamab – NSCLC EGFR. The Food and Drug Administration (FDA) approved the EGF and MET receptor targeted antibody with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
  • September 25 – Osimertinib – NSCLC EGFR. The Food and Drug Administration (FDA) approved the third-generation EGFR tyrosine kinase inhibitor for the treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
  • September 27 – Selpercatinib – MTC RET. The Food and Drug Administration (FDA) changed from accelerated to traditional the approval of the RET receptor tyrosine kinase inhibitor for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.
  • October 3 – Nivolumab – NSCLC EGFR/ALK. The Food and Drug Administration (FDA) approved the PD-1 blocking antibody with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ? 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
  • October 10 – Inavolisib – BC PIK3CA. The Food and Drug Administration (FDA) approved the PI3K? inhibitor with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
  • October 29 – Asciminib – CML BCR-ABL1. The Food and Drug Administration (FDA) granted accelerated approval to the inhibitor of ABL/BCR-ABL1 tyrosine kinase for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).