New cancer medicines and extended therapeutic indications are recommended for approval in the EU, as reported by the newest issue of European Regulatory Oncology  newsletter, providing the excellent updates on the regulatory decisions of the Committee for Medicinal Products for Human Use (CHMP) on innovative medicines for the treatment of cancer. Non-small cell lung cancer (NSCLC) is a serious and often fatal disease that accounts for 80 to 85% of all lung cancers.

A significant number of NSCLC patients present with driver mutations in oncogenes, some of which can be aimed at by targeted therapies while patients without known driver mutations need broader-acting therapies.

Cejemly (sugemalimab) has received a positive opinion for the first-line treatment, in combination with platinum-based chemotherapy, of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. Sugemalimab is a monoclonal antibody which targets PD-L1 (programmed cell death ligand 1). Many cancer cells express a PD-1 ligand. Since activation of PD-1 down-regulates the immune system, blocking of the interaction between PD-1 and PD-L1 enhances the T cell responses against the cancer cells.

Tagrisso (osimertinib) has received a recommendation for the extension of indication in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Osimertinib is an orally available small molecule which belongs to the class of tyrosine kinase inhibitors. It irreversibly inhibits the epidermal growth factor receptor (EGFR), especially if it harbours the mutations mentioned in the indication.

Tevimbra (tislelizumab) has received a recommendation for the extension of indication to include several treatment settings of non-small cell lung cancer. These include: i) combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations: ii) combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC iii) treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab. Like sugemalimab (Cejemly) mentioned above, tislelizumab is a checkpoint inhibitor. While sugemalimab inhibits PD-L1, tislelizumab inhibits the corresponding receptor, PD-1, which is expressed on the surface of many cancer cells.