EMA

January 9 – Osimertinib – NSCLC EGFR. The European Commission (EC) has approved a Type II variation extension of indication for the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), as monotherapy, to include treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.

January 13 – Nivolumab + ipilumab – CRC MSI. The European Commission (EC) has approved the extension of indication to include nivolumab (anti-PD-1 antibody) in combination with ipilumab (anti-CTLA4 antibody) in the first-line treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer.

January 13 – Repotrectinib – NSCLC ROS1 / Solid Tumours NTRK. The European Commission (EC) granted a conditional marketing authorisation to the next-generation tyrosine kinase inhibitor (TKI) for the following indications:

  • as monotherapy, for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC);
  • as monotherapy, for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted.

CHMP

February 27 – Durvalumab – NSCLC EGFR/ALK. The Committee for Medicinal Products for Human Use (CHMP) adopted a new indication to include treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The full indications for the anti-PD-L1 monoclonal antibody will therefore be as follows: durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy, as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.

FDA

January 16 – Sotorasib – CRC KRAS.  The Food and Drug Administration (FDA) approved the KRAS inhibitor with panitumumab for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

January 7 – Sunvozertinib – NSCLC EGFR. The Food and Drug Administration (FDA) has granted priority review to the New Drug Application (NDA) for the oral EGFR inhibitor for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

January 8 – Invikafusp – CRC TMB. The Food and Drug Administration (FDA) has granted Fast Track Designation to the first-in-class TCR ? chain-targeted bispecific antibody as a potential new treatment for advanced colorectal cancer with high tumor mutation burden (TMB-H).

January 9 – BBO-8520 – NSCLC KRAS. The Food and Drug Administration (FDA) has granted Fast Track Designation to the KRAS inhibitor for the treatment of adult patients with previously treated, KRAS G12C -mutated metastatic non-small cell lung cancer (NSCLC).

January 13 – Dapotomab Derutecan – NSCLC EGFR. The Food and Drug Administration (FDA) has accepted and granted priority review to the biologics license application (BLA) for the TROP2 directed DXd antibody drug conjugate. Dato-DXd is intended for the treatment of adults patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who have previously received systemic therapies, including EGFR-targeted treatments.

February 18 – Dordaviprone – HGG H3K27M. The Food and Drug Administration (FDA) has accepted and given priority review to a New Drug Application (NDA) for the accelerated approval of dordaviprone for treating patients with recurrent H3 K27M-mutant diffuse high grade glioma (HGG). Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2).

February 19 – Zongertinib – NSCLC HER2. The Food and Drug Administration (FDA) has granted priority review to the New Drug Application (NDA) for the irreversible HER2-selective tyrosine kinase inhibitor for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) mutations and who have received prior systemic therapy.