CHMP
January 29. Niraparib + Abiraterone acetate – mHSPC BRCA1/2 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 dual-action tablet: niraparib/abiraterone acetate is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).
January 29. Ponatinib – ALL 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 is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia.
February 26. Tovorafenib – LGG BRAF. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the type II RAF kinase inhibitor, intended for the treatment of paediatric low-grade glioma (LGG) with BRAF alterations, in patients aged 6 months and older whose disease has progressed after one or more prior systemic therapies.
February 26. Asciminib – CML BCR-ABL. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a new indication for the inhibitor of ABL/BCR-ABL1 tyrosine kinase: asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib.
EMA
February 12. Aumolertinib – NSCLC EGFR. The European Commission has granted the marketing authorisation to 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 tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations;
- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC
FDA
January 06. Sevabertinib – NSCLC HER2. The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to sevabertinib (formerly BAY 2927088) for the first-line treatment of patients with unresectable or metastatic non–small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations. Sevabertinib is an investigational, oral, highly selective tyrosine kinase inhibitor (TKI) designed to target both HER2 and EGFR mutations, with specific potency against HER2 exon 20 insertions and point mutations.
January 08. ETX-19477 – HGSOC BRCA. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the PARG inhibitor for the treatment of adult patients with BRCA-mutated, platinum-resistant, high-grade serous ovarian cancer (HGSOC).
January 08. Zoldonrasib – NSCLC KRAS. The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to the RAS(ON) inhibitor for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.
January 20. Gedatolisib – BC PIK3CA. The U.S. Food and Drug Administration (FDA) has granted Priority Review to the multi-target PI3K/AKT/mTOR (“PAM”) inhibitor for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-type advanced breast cancer (“ABC”). Gedatolisib previously received both Breakthrough Therapy and Fast Track designations.
January 26. Bezuclastinib – GIST KIT. The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to bezuclastinib, in combination with sunitinib, for the treatment of patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17.
February 05. Capecitabine/5-FU DPYD. The U.S. Food and Drug Administration (FDA) approved the following changes to the capecitabine and 5-FU product labelling:
- The “Boxed Warning” advises DPYD testing prior to initiating capecitabine or 5-FU, unless immediate treatment is necessary, and recommends avoiding use in patients with certain homozygous or compound heterozygous DYPD variants that result in complete DPD deficiency.
- In the “Dosage and Administration” section, a new subsection, 2.1 “Evaluation and Testing for DPD Deficiency Before Initiating capecitabine or 5-FU”, has been added and instructs to avoid use of these drugs in patients known to have certain homozygous or compound heterozygous DYPD variants that result in complete DPD deficiency. For patients with partial DPD deficiency, dosing should be individualized.
- The “Warnings and Precautions” section reiterates that prior to initiating capecitabine or 5-FU, patients should be tested for genetic variants of the DPYD gene unless immediate treatment is necessary.
February 24. Encorafenib + cetuximab – CRC BRAF. The U.S. Food and Drug Administration (FDA) has granted full approval to encorafenib (BRAF inhibitor) in combination with cetuximab (anti-EGFR monoclonal antibody) and fluorouracil-based chemotherapy for the first-line treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial.
February 26. Zongertinib – NSCLC HER2. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to the anti-HER2 tyrosine kinase inhibitor for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
February 3. Zovegalisib – BC PIK3CA. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to the mutant-selective PI3Kα allosteric inhibitor, in combination with fulvestrant, for the treatment of adults with PIK3CA mutant, hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
February 4. Pelareorep – CRC KRAS. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational oncolytic virus immunotherapy, in combination with bevacizumab and leucovorin, fluorouracil, irinotecan (FOLFIRI), for the treatment of patients with KRAS -mutant, microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) in the second-line (2L) setting.
February 23. ART6043 – BC BRCA The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the potentially first-in-class DNA polymerase theta (Polθ) inhibitor, in combination with the PARP inhibitor, olaparib, for the treatment of adult patients with germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer who have received no prior treatment with a PARP inhibitor.
AIFA
January 13. Pembrolizumab – EC MSI. The Italian Medicines Agency (AIFA) has approved the reimbursement for the new therapeutic indication of the anti-PD-1 monoclonal antibody: pembrolizumab, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of advanced or recurrent primary endometrial cancer in adults who are candidates for systemic therapy and have a mismatch repair deficiency (dMMR/MSI-H).
February 3. Olaparib – PDAC BRCA1/2. The Italian Medicines Agency (AIFA) has approved the reimbursement for the new therapeutic indication of the poly (ADP-ribose) polymerase (PARP) inhibitor: olaparib is indicated as monotherapy for the maintenance treatment of adult patients with metastatic adenocarcinoma of the pancreas and germline BRCA1/2 mutations who have not experienced disease progression after a minimum of 16 weeks of platinum-based treatment in a first-line chemotherapy regimen.
February 9. Sugemalimab – NSCLC EGFR/ALK/ROS1. The Italian Medicines Agency (AIFA) has decided to include the anti-PD-L1 monoclonal antibody in the specific section (called class C (nn)) dedicated to medicines that have not yet been assessed for reimbursement purposes.
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 ALK, ROS1 or RET tumour gene aberrations.
Sugemalimab, as monotherapy, is indicated for the treatment of unresectable stage III NSCLC in the absence of EGFR sensitising mutations or ALK or ROS1 tumour gene aberrations in adults whose tumours express PD-L1 ≥1% on tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.
February 25. Lazertinib – NSCLC EGFR. The Board of Directors of the Italian Medicines Agency (AIFA) has approved the third-generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the first-line treatment, in combination with amivantamab, of adult patients with advanced non-small cell lung cancer with deletions in exon 19 or L858R substitution mutations in exon 21 of EGFR.
February 25. Amivantamab – NSCLC EGFR. The Board of Directors of the Italian Medicines Agency (AIFA) has approved the extension of indications of the anti-EGFR-MET bispecific antibody. Amivantamab is indicated for:
- the first-line treatment, in combination with lazertinib, of adult patients with advanced non-small cell lung cancer with deletions in exon 19 or L858R substitution mutations in exon 21 of EGFR.
- The first-line treatment, in combination with carboplatin and pemetrexed, of adult patients with advanced non-small cell lung cancer with deletions in exon 19 or L858R substitution mutations in exon 21 of EGFR after failure of previous therapy including an EGFR tyrosine kinase inhibitor (TKI).
- The first-line treatment, in combination with carboplatin and pemetrexed, of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations.
February 25. Nivolumab – CRC MSI. The Board of Directors of the Italian Medicines Agency (AIFA) has approved the extension of indications of the anti-PD-1 monoclonal antibody: nivolumab, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic colorectal cancer with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H).
February 25. Ipilimumab – CRC MSI. The Board of Directors of the Italian Medicines Agency (AIFA) has approved the extension of indications of the CTLA-4 blocking monoclonal antibody: ipilimumab, in combination with nivolumab, is indicated for the first-line treatment of adult patients with metastatic colorectal cancer with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H).