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New FDA and EMA Oncology Drug Approvals in Q3 2024 Largely Focused on NSCLC and Other Solid Tumors

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
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
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
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.

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

https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Healths-Shield-Blood-Test-Approved-by-FDA-as-a-Primary-Screening-Option-Clearing-Path-for-Medicare-Reimbursement-and-a-New-Era-of-Colorectal-Cancer-Screening/default.aspx

https://www.oncologynewscentral.com/article/groundbreaking-t-cell-therapy-poised-to-change-cancer-care?ap=nl2103&rhid=VHBR00317216129&mui=&lid=70677189&mkt_tok=NTQxLUdL-Wi0yNDMAAAGUsfyuZkdEVG00U6WsnxMZpjcAPXKRTe03el_bonL3IC8PiYVen-Qqcz21RwV-Nj-sPaWcozX0isSy

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