The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 25 new or expanded indications for previously approved agents and 6 new oncology agents in the third quarter of the year. The approvals were for approximately 22 solid tumor types and 4 hematologic malignancies. More than half of the approvals were for biologics or biosimilars; there were 15 biologics approved, and 2 biosimilars approved. One treatment was approved by both the FDA and the EMA for a new indication: amivantamab-vmjw (Rybrevant®; Janssen Biotech [US]; Janssen-Cilag [EU]), an epidermal growth factor receptor-mesenchymal epithelial transition (EGFR-MET) bispecific antibody approved for treatment of non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with carboplatin and pemetrexed.
Additional highlights from the third quarter of 2024
- The first engineered cell therapy for a solid tumor was approved: afamitresgene autoleucel (Tecelra®; Adaptimmune), a genetically modified autologous T-cell immunotherapy, received accelerated approval by the FDA for treatment of synovial sarcoma
- The first subcutaneous programmed cell death protein 1 ligand 1 (PD-L1) inhibitor, atezolizumab + hyaluronidase-tqjs (Tecentriq Hybreza™; Genentech), received FDA approval for all the adult indications of the intravenous formulation of atezolizumab
- Vorasidenib (Voranigo®; Servier), the first systemic therapy for patients with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase 1 (IDH1) or IDH2 mutation, was approved by the FDA
- There were 6 monoclonal antibody approvals and 2 bispecific antibody approvals
- NSCLC agents represent the highest number of approvals (9), followed by breast cancer (4), gastric cancer (3), and multiple myeloma (3)
- One product that previously received accelerated approval gained full approval by the FDA
- Selpercatinib (Retevmo®; Eli Lilly and Company) for rearranged during transfection (RET)-mutant medullary thyroid cancer
- The most common molecular targets were PD-1/PD-L1 (5 approvals for each)
- Pembrolizumab (Keytruda®; Merck) continued to receive approvals for new indications by both the FDA and EMA
- Two diagnostics were approved by the FDA
- Shield™ (Guardant), a blood-based colorectal cancer screening test
- FoundationOne® CDx and FoundationOne Liquid CDx (Foundation Medicine), a companion diagnostic for olaparib, for diagnosing breast cancer gene (BRCA)-mutated metastatic castration-resistant prostate cancer
- The application for atezolizumab (Tecentriq®; Roche) for a hepatocellular carcinoma indication in combination with bevacizumab was withdrawn from the EMA in September
The tables below summarize key Q3 2024 oncology approvals. Treatments in bold font represent new agent approvals by each agency; all others are indication expansions or conversion from accelerated to full approval (FDA).
FDA and EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Amivantamab-vmjwb |
Rybrevant® |
NSCLC (combination therapy) |
Bispecific antibody |
Janssen Biotech (US); Janssen-Cilag (EU) |
9/19/24 (FDA) and July 2024 (EMA)c |
FDA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Afamitresgene autoleucelb |
Tecelra |
Synovial sarcoma |
Immunotherapy |
Adaptimmune |
8/2/24d |
Amivantamab-vmjwb |
Rybrevant® |
NSCLC (monotherapy) |
Bispecific antibody |
Janssen Biotech |
8/19/24 |
Atezolizumab + hyaluronidase-tqjsb |
Tecentriq Hybreza |
NSCLC, SCLC, HCC, melanoma, ASPS |
PD-L1 inhibitor |
Genentech |
9/12/24 |
Daratumumab + hyaluronidase-fihjb |
Darzalex Faspro® |
Multiple myeloma |
Anti-CD38 monoclonal antibody |
Janssen Biotech |
7/30/24 |
Denileukin diftitox-cxdlb |
Lymphir™ |
CTCL |
Immunotherapy |
Citius Pharma |
8/7/24 |
Dostarlimabb |
Jemperli® |
Endometrial cancer |
PD-1 inhibitor |
GlaxoSmithKline |
8/1/24 |
Durvalumabb |
Imfinzi® |
NSCLC |
PD-L1 inhibitor |
AstraZeneca |
8/15/24 |
Isatuximab-irfcb |
Sarclisa® |
Multiple myeloma |
Anti-CD38 monoclonal antibody |
Sanofi-Aventis |
9/20/24 |
Lazertinib |
Lazcluze™ |
NSCLC |
EGFR TKI |
Janssen Biotech |
8/19/24 |
Octreotide acetate |
Bynfezia pen™ |
Carcinoid tumors, VIPomas |
Somatostatin analogue |
Sun Pharmaceutical Industries |
9/27/24 |
Osimertinib |
Tagrisso® |
NSCLC |
EGFR TKI |
AstraZeneca |
9/25/24 |
Pembrolizumabb |
Keytruda® |
Malignant pleural mesothelioma |
PD-1 inhibitor |
Merck |
9/17/24 |
Ribociclib succinate |
Kisqali® |
Breast cancer (advanced metastatic) |
CDK4/6 inhibitor |
Novartis |
7/22/24 |
Ribociclib succinate |
Kisqali® |
Early breast cancer |
CDK4/6 inhibitor |
Novartis |
9/17/24 |
Ribociclib succinate; letrozole |
Kisqali®– Femara® co-pack |
Early breast cancer |
CDK4/6 inhibitor; aromatase inhibitor |
Novartis |
9/17/24 |
Selpercatinib |
Retevmo |
RET-positive medullary thyroid cancer |
RET inhibitor |
Eli Lilly |
9/27/24 |
Vorasidenib |
Voranigo |
Astrocytoma or oligodendroglioma |
IDH1 and IDH2 inhibitor |
Servier |
4/25/24 |
EMA Approvals |
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Generic Name |
Brand Name |
Tumor Typea |
MOA |
Manufacturer |
Approval |
Atezolizumabb |
Tecentriq |
1L NSCLC |
PD-L1 inhibitor |
Roche |
July 2024c |
Binimetinib |
Mektovi® |
NSCLC with BRAF V600E mutation |
MEK inhibitor |
Pierre Fabre Médicament |
July 2024c |
Daratumumabb |
Darzalex® |
Multiple myeloma |
Anti-CD38 monoclonal antibody |
Janssen-Cilag |
September 2024c |
Encorafenib |
Braftovi® |
NSCLC with BRAF V600E mutation |
BRAF inhibitor |
Pfizer |
July 2024c |
Enfortumab vedotin |
Padcev® |
Urothelial cancer |
Antibody-drug conjugate |
Astellas Pharma |
July 2024c |
Mirvetixumab soravtansine-gynx |
Elahere™ |
Ovarian, fallopian tube, or primary peritoneal cancer |
Antibody-drug conjugate |
AbbVie Deutschland |
September 2024e |
Pembrolizumabb |
Keytruda |
Urothelial carcinoma |
PD-1 inhibitor |
Merck Sharp & Dohme |
July 2024c |
Pembrolizumabb |
Keytruda |
Cervical cancer |
PD-1 inhibitor |
Merck Sharp & Dohme |
September 2024c |
Rituximabf |
Ituxredi |
NHL, CLL |
Anti-CD20 monoclonal antibody |
Reddy Holding |
July 2024c |
Serplulimab |
Hetronifly® |
SCLC |
PD-1 inhibitor |
Henlius Europe |
September 2024e |
Toripalimab-tpzib |
Loqtorzi™ |
Nasopharyngeal carcinoma, esophageal squamous cell carcinoma |
PD-L1 inhibitor |
TMC Pharma |
July 2024c |
Trastuzumabf |
Tuznue® |
Breast and gastric cancers |
HER2-targeted monoclonal antibody |
Prestige Biopharma |
July 2024c |
Zolbetuximab |
Vyloy™ |
Gastric or GEJ adenocarcinoma |
Anti-claudin 18.2 monoclonal antibody |
Astellas Pharma |
July 2024e |
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.bBiologic.cPositive opinion.dAccelerated approval.eMarketing authorization.fBiosimilar.1L, first-line; ASPS, alveolar soft part sarcoma; BRAF, v-raf murine sarcoma viral oncogene homolog B1; BRCA, breast cancer gene; CDK4/6, cyclin-dependent kinase 4/6; CLL, chronic lymphocytic leukemia; CTCL, cutaneous T-cell lymphoma; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; FDA, US Food and Drug Administration; GEJ, gastroesophageal junction; HCC, hepatocellular carcinoma; HER2, human epidermal growth factor receptor 2; IDH1, isocitrate dehydrogenase 1; IDH2, isocitrate dehydrogenase 2; MEK, mitogen-activated protein kinase kinase; MOA, mechanism of action; NHL, non-Hodgkin lymphoma; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; PD-L1, PD-1 ligand 1; RET, rearranged during transfection; SCLC, small cell lung cancer; TKI, tyrosine kinase inhibitor; VIPoma, vasoactive intestinal peptide-secreting tumor. |
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Sources:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights
