CHMP (Committee for Medicinal Products for Human Use- EMA)
May 21 Camizestrant – BC ESR1. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation for the oral selective oestrogen receptor degrader (ngSERD) and complete oestrogen receptor (ER) antagonist., intended for the treatment of adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 gene mutations and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor.
May 21 Alpelisib – PROS PIK3CA. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the PI3K inhibitor, intended for the treatment of adults and children aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.
May 21 Encorafenib – CRC BRAF. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending a new indication for the BRAF kinase inhibitor: encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.
May 21 Cetuximab – CRC BRAF. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending two new indications for the anti-EGFR monoclonal antibody:
- cetuximab is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib in patients who have received prior systemic therapy;
- cetuximab is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib and FOLFOX for the first line treatment.
May 21 Ponatinib – CP-CML BCR-ABL. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending a new indication for the Bcr-Abl tyrosine kinase inhibitor: ponatinib is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
EMA
May 13 Serplulimab – NSCLC EGFR/ALK. The European Commission (EC) has approved the extension of indication for the Anti-PD-1 monoclonal antibody to include serplulimab in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non squamous non-small cell lung carcinoma who do not have EGFR or ALK mutations.
May 19 Dabrafenib – DTC BRAF. The European Commission (EC) has approved the extension of indication for the BRAF kinase inhibitor to include dabrafenib plus trametinib in previously treated patients with locally advanced or metastatic, radio-active iodine refractory BRAF V600E mutation-positive differentiated thyroid cancer.
May 19 Trametinib – DTC BRAF. The European Commission (EC) has approved the extension of indication for the MEK1 and MEK2 kinase inhibitor to include trametinib plus dabrafenib in previously treated patients with locally advanced or metastatic, radio-active iodine refractory BRAF V600E mutation-positive differentiated thyroid cancer.
FDA
May 1 Vepdegestrant – BC ESR1. The U.S. Food and Drug Administration (FDA) has granted approval for the proteolysis-targeting chimera (PROTAC) estrogen receptor degrader for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
May 8 Zenocutuzumab – CCA NRG1. The U.S. Food and Drug Administration (FDA) has approved the bispecific HER2- and HER3-directed bispecific antibody for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This marks the first targeted therapy approved specifically for NRG1+ cholangiocarcinoma, a molecularly defined cancer with a profound unmet need.
May 15 Atezolizumab – MIBC ctDNA. The U.S. Food and Drug Administration (FDA) has approved the anti-PD-L1 antibody as an adjuvant treatment for adult patients with muscle-invasive bladder cancer who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by an FDA-authorized test.
May 13 Suplexa – CRC MSI. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the autologous, non-engineered cellular therapy platform for the treatment of patients with colorectal cancer of the MSI-H phenotype.
May 18 Sevabertinib – NSCLC HER2. The U.S. Food and Drug Administration (FDA) has granted the HER2 tyrosine kinase inhibitor (TKI) Priority Review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations in patients with no prior therapy.
May 27 Neladalkib – NSCLC ALK. The U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for the investigational ALK-selective inhibitor for filing, granting the priority review for the treatment of tyrosine kinase inhibitor (TKI)-pretreated advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
AIFA
May 26 Aumolertinib – NSCLC EGFR. The Italian Medicines Agency (AIFA) has authorised the marketing of the third-generation EGFR tyrosine kinase inhibitor. Aumolertinib as monotherapy is indicated for:
- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumour harbours EGFR exon 19 deletions or an exon 21 substitution mutation (L858R);
- the treatment of adult patients with advanced NSCLC positive for the T790M mutation in EGFR.