NOVEMBER – DECEMBER 2024 Shooting Cancer Highlights: Periodic focus on regulatory status of new targeted therapies in oncology
EMA December 30 – Lazertinib + amivantamab – NSCLC EGFR. The European Commission (EC) has approved a Type II variation extension of indication for amivantamab (anti-EGFR-MET bispecific antibody), in combination with lazertinib (third-generation EGFR tyrosine kinase inhibitor), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor […]
AUGUST – OCTOBER 2024 Shooting Cancer Highlights: Periodic focus on regulatory status of new targeted therapies in oncology
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 […]
JUNE – AUGUST 2024 Shooting Cancer Highlights: Periodic focus on regulatory status of new targeted therapies in oncology
EMA June 17 – Capivasertib – BC PIK3CA/AKT1/PTEN. The European Commission (EC) has authorised the marketing of the serine/threonine kinase inhibitor. Capivasertib is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. July 3 – Entrectinib – Solid Tumours NTRK. […]
MAY – JUNE 2024 Shooting Cancer Highlights: Periodic focus on regulatory status of new targeted therapies in oncology
EMA May 28 – Selpercatinib – Solid Tumours RET. The European Commission (EC) has approved the extension of indication for the RET receptor tyrosine kinase inhibitor to include the treatment, in monotherapy, of adults with advanced or metastatic RET fusion-positive solid tumours with disease progression on or after prior systemic therapies or who have no […]
MARCH – APRIL 2024 Shooting Cancer Highlights: Periodic focus on regulatory status of new targeted therapies in oncology
EMA April 23 – Tislelizumab – NSCLC EGFR/ALK. The European Commission (EC) has approved the anti-PD-1 monoclonal antibody, across 3 indications for the first- and second-line treatment of adult patients with non–small cell lung cancer (NSCLC). In particular, tislelizumab, in combination with pemetrexed and platinum?containing chemotherapy, is indicated for the first-line treatment of adult patients […]
NOVEMBER 2023 – FEBRUARY 2024 Shooting Cancer Highlights: Periodic focus on regulatory status of new targeted therapies in oncology
EMA November 15 – Dabrafenib – LGG/HGG BRAF. The BRAF inhibitor has been approved in the European Union for the following therapeutic indications: treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy, in combination with trametinib; treatment of paediatric patients aged 1 […]