EMA
April 22. Tovorafenib – LGG BRAF. The European Commission (EC) has granted conditional marketing authorization for the Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade-glioma harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
FDA
April 1. Plixorafenib – HGG BRAF. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to the novel BRAF inhibitor for the treatment of adults with BRAF V600E-mutated high-grade glioma (HGG).
April 20. BBO-11818 – PDAC KRAS. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational selective, orally bioavailable non-covalent KRAS inhibitor for the treatment of adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma.
April 27. TERN-701 – CML BCR-ABL. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to the novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP) without the T315I mutation previously treated with two or more tyrosine kinase inhibitors (TKIs).
AIFA
April 20. Nivolumab – CRC MSI. The Italian Medicines Agency (AIFA) has approved the reimbursement for three new therapeutic indications of the anti-PD-1 monoclonal antibody, including the following: nivolumab, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic colorectal cancer with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H).
April 20. Ipilimumab – CRC MSI. The Italian Medicines Agency (AIFA) has approved the reimbursement for the new therapeutic indication of the CTLA-4 blocking monoclonal antibody: ipilimumab, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic colorectal cancer with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H).
AIFA has approved the reimbursement also for other therapeutic indications of the Anti-CTLA-4 antibody subject to renegotiation, including the following:
- ipilimumab, in combination with nivolumab and two cycles of platinum-based chemotherapy, is indicated for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumour does not express EGFR mutations or ALK translocations and has a PD-L1 expression of <50%;
- ipilimumab, in combination with nivolumab, is indicated for the treatment of adult patients with metastatic colorectal cancer with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) following prior combination chemotherapy based on fluoropyrimidine.
April 21. Imlunestrant – BC ESR1. The Italian Medicines Agency (AIFA) has authorised the marketing of the estrogen receptor (ER) antagonist. Imlunestrant is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic, HER2-negative, oestrogen receptor (ER)-positive breast cancer with an activating ESR1 mutation, whose disease has progressed following prior treatment with an endocrine therapy regimen.
April 22. Durvalumab – EC MMR / NSCLC EGFR, ALK. The Italian Medicines Agency (AIFA)’s Board of Directors approved reimbursement eligibility for four extensions of therapeutic indication concern the anti-PD-L1 monoclonal antibody including the following:
- durvalumab, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with advanced or recurrent primary endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with durvalumab as monotherapy in mismatch repair-deficient (dMMR) endometrial cancer, or with durvalumab in combination with olaparib in mismatch repair-proficient endometrial cancer (pMMR).
- durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable non-small cell lung cancer at high risk of recurrence and in the absence of EGFR mutations or ALK rearrangements;
- durvalumab, in combination with tremelimumab and platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer who do not have sensitising mutations in EGFR or ALK mutations.
April 22. Sugemalimab – NSCLC EGFR, ALK/ROS1/RET. The Italian Medicines Agency (AIFA) has authorised the marketing of the anti-PD-L1 monoclonal antibody.
Sugemalimab, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) in the absence of EGFR sensitising mutations or tumour aberrations in the ALK, ROS1 or RET genes.
Sugemalimab as monotherapy is indicated for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) in the absence of sensitising EGFR mutations or tumour ALK or ROS1 gene alterations in adults whose tumour exhibits PD-L1 expression ≥ 1% on tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.