New FDA and EMA Oncology Drug Approvals in Q2 2024 Largely Focused on Biologics and Specific Molecular Targets
Medical Advances

New FDA and EMA Oncology Drug Approvals in Q2 2024 Largely Focused on Biologics and Specific Molecular Targets

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continued 2024 with 26 new or expanded indications for previously approved agents and 9 new oncology agents in the second quarter of the year. The approvals were for approximately 19 solid tumor types and 5 hematologic malignancies. More than half of the approvals were for biologics or biosimilars; there were 17 biologics approved and 3 biosimilars. Three treatments were approved by both the FDA and the EMA for new indications: alectinib (Alecensa®; Roche), an anaplastic lymphoma kinase inhibitor; durvalumab (Imfinzi®; AstraZeneca), a programmed death-ligand 1 (PD-L1) blocker; and epcoritamab (Epkinly® [US]/Tepkinly® [EU]; Genmab/AbbVie), a bispecific antibody.

 

Additional highlights from the second quarter of 2024

  • There were 6 approvals of treatments for non-small cell lung cancer
  • There were 4 solid tumor-agnostic approvals, reflecting the increasing shift toward precision oncology and molecular profiling in oncology research
    • Trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo), the first human epidermal growth factor receptor 2-directed treatment and antibody-drug conjugate to receive a tumor-agnostic indication from the FDA
    • Entrectinib (Rozlytrek®; Roche), for solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion, with the indication for patients aged 12 years and older expanded to include pediatric patients aged 1 month or older
    • Repotrectinib (Augtyro™; Bristol Myers Squibb), for solid tumors with NTRK gene fusion
    • Selpercatinib (Retevmo®; Eli Lilly and Company), for solid tumors with rearranged during transfection gene fusion, with the indication expanded to include pediatric patients aged 2 and older
  • 3 biologic agents were approved for treatment of follicular lymphoma
    • Epcoritamab (Epkinly® [US]/Tepkinly® [EU]; Genmab/AbbVie), a bispecific antibody
    • Lisocabtagene maraleucel (Breyanzi®; Juno Therapeutics), a chimeric antigen receptor (CAR) T-cell therapy
    • Odronextamab (Ordspono; Regeneron), a bispecific antibody
  • 2 products that previously received accelerated approval gained full approval by the FDA
    • Selpercatinib (Retevmo; Eli Lilly and Company) for thyroid cancer
    • Tisotumab vedotin-tftv (Tivdak®; Pfizer) for cervical cancer
  • The most common molecular targets were programmed cell death protein 1/PD-L1
  • There were 4 bispecific antibody approvals
  • Additional safety information was added by the FDA to the labels for all Bruton tyrosine kinase inhibitors regarding risk of hepatotoxicity, including drug-induced liver injury, and risk of cardiac arrhythmia, including ventricular arrhythmia
  • The EMA issued a directive in June requiring all CAR T-cell therapies to include written warning of the associated risk for secondary blood cancers

The tables below summarize key Q2 2024 oncology approvals. Treatments in bold font represent new agent approvals; all others are indication expansions or conversions from accelerated to full approvals (FDA).

FDA and EMA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Alectinibb
Alecensa®
ALK+ NSCLC
ALK inhibitor
Hoffman-La Roche (US); Roche (EU)
4/18/24 (FDA) and April 2024 (EMA)c
Durvalumabb
Imfinzi®
Endometrial cancer
PD-L1 blocker
AstraZeneca
6/14/24 (FDA) and June 2024 (EMA)c
Epcoritamabb
Epkinly® (US); Tepkinly® (EU)
Follicular lymphoma
Bispecific antibody
Genmab; AbbVie
6/26/24 (FDA)d and June 2024 (EMA)c

FDA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Adagrasib
Krazati®
Colorectal cancer
KRAS G12C inhibitor
Mirati Therapeutics (now Bristol Myers Squibb)
6/21/24d
Blinatumomabb
Blincyto®
Ph– BCP ALL
Bispecific T-cell engager
Amgen
6/14/24
Ciltacabtagene autoleucelb
Carvykti®
Multiple myeloma
CAR T
Johnson & Johnson
4/5/24
Fam-trastuzumab deruxtecan-nxkib
Enhertu®
HER2+ solid tumors
Antibody-drug conjugate
Daiichi Sankyo
4/5/24d
Filgrastim-txide
Nypozi™
Supportive care, neutropenia
Leukocyte growth factor
Tanvex BioPharma
6/28/24
Idecabtagene vicleucelb
Abecma®
Multiple myeloma
CAR T
Bristol Myers Squibb
4/4/24
Imetelstat
Rytelo™
MDS
Oligonucleotide telomerase inhibitor
Geron
6/6/24
Lisocabtagene maraleucelb
Breyanzi®
Follicular lymphoma
CAR T
Juno Therapeutics
5/15/24d
Lutetium Lu 177 dotatate
Lutathera®
GEP-NETs (pediatric)
Radiopharmaceutical
Novartis
4/24/24
Nogapendekin alfa inbakicept-pmlnb
Anktiva®
Bladder cancer
Interleukin-15 superagonist
Altor BioScience
4/22/24
Pegulicianine
Lumisight™
Breast cancer diagnostic
Optical imaging agent
Lumicell
4/18/24
Pembrolizumabb
Keytruda®
Endometrial cancer
PD-1 inhibitor
Merck
6/17/24
Repotrectinib
Augtyro™
Solid tumors with NTRK gene fusion
ROS1 inhibitor
Bristol Myers Squibb
6/13/24d
Selpercatinib
Retevmo®
Solid tumors with RET gene fusion
RET inhibitor
Eli Lilly and Company
5/29/24
Selpercatinib
Retevmo
Thyroid cancer
RET inhibitor
Eli Lilly and Company
6/12/24
Tarlatamab-dlleb
Imdelltra™
SCLC
T-cell engager therapy
Amgen
5/16/24d
Tisotumab vedotin-tftv
Tivdak®
Cervical cancer
Antibody-drug conjugate
Seagen (now Pfizer)
4/29/24
Tovorafenib
Ojemda™
Pediatric glioma
RAF kinase inhibitor
Day One Biopharmaceuticals
4/23/24d
Trastuzumab-strfe
Hercessi
Breast cancer, gastric cancer,
GEJ adeno-
carcinoma
HER2/neu receptor antagonist
Accord BioPharma
4/25/24

EMA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Amivantamab-vmjwb
Rybrevant®
NSCLC
Bispecific antibody
Johnson & Johnson
April 2024c
Bevacizumabe
Avzivi®
NSCLC, colorectal, breast, renal cell, cervical, epithelial ovarian, fallopian tube, and primary peritoneal cancers
VEGF inhibitor
FGK Representative Service
May 2024c
Capivasertib
Truqap™
ER+ breast cancer
AKT1 inhibitor
AstraZeneca
April 2024c
Crizotinib
Xalkori®
ALK+ large-cell lymphoma; inflammatory myofibroblastic tumor (pediatric)
TKI
Pfizer Europe
June 2024c
Entrectinib
Rozlytrek®
Solid tumors with NTRK gene fusion (pediatric)
TRK and ROS1 inhibitor
Roche
April 2024c
Erdafitinib
Balversa®
Urothelial carcinoma
FGFR TKI inhibitor
Janssen-Cilag
June 2024f
Fruquintinib
Fruzaqla®
Colorectal cancer
VEGF inhibitor
Takeda
April 2024c
Nivolumabb
Opdivo®
Urothelial carcinoma
PD-1 inhibitor
Bristol Myers Squibb
April 2024c
Odronextamabb
Ordspono
Follicular lymphoma and DLBCL
Bispecific antibody
Regeneron
June 2024g
Olaparibb
Lynparza®
Endometrial cancer
PARP inhibitor
AstraZeneca
June 2024c
Sugemalimabb
Cejemly®
NSCLC
PD-1 inhibitor
SFL Pharmaceuticals
May 2024c
Osimertinib
Tagrisso®
NSCLC
EGFR TKI
AstraZeneca
May 2024c
Tislelizumabb
Tevimbra®
NSCLC
PD-1 inhibitor
BeiGene Ireland
May 2024c
 

AKT1, serine/threonine protein kinase 1; ALK, anaplastic lymphoma kinase; ALL, acute lymphocytic leukemia; BCP, B-cell precursor; CAR T, chimeric antigen receptor T-cell; DLBCL, diffuse large b-cell lymphoma; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; ER, estrogen receptor; FDA, US Food and Drug Administration; FGFR, fibroblast growth factor receptor; GEJ, gastroesophageal junction; GEP-NETs, gastroenteropancreatic neuroendocrine tumors; HER2, human epidermal growth factor receptor 2; KRAS, Kirsten rat sarcoma viral oncogene; MDS, myelodysplastic syndrome; MOA, mechanism of action; NSCLC, non-small cell lung cancer; NTRK, neurotrophic tyrosine receptor kinase; PARP, poly(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; Ph, Philadelphia chromosome; RAF, rapidly accelerated fibrosarcoma; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1, receptor tyrosine kinase; SCLC, small cell lung cancer; TKI, tyrosine kinase inhibitor; TRK, tropomyosin receptor kinase; VEGF, vascular endothelial growth factor.
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
bBiologic.
cPositive opinion.
dAccelerated approval.
eBiosimilar.
fMarketing authorization.
gConditional marketing authorization.

 

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://news.bms.com/news/corporate-financial/2024/U.S.-FDA-Approves-Bristol-Myers-Squibb-and-2seventy-bios-Abecma-for-Triple-Class-Exposed-Relapsed-or-Refractory-Multiple-Myeloma-After-Two-Prior-Lines-of-Therapy/default.aspx

https://www.jnj.com/media-center/press-releases/carvykti-is-the-first-and-only-bcma-targeted-treatment-approved-by-the-u-s-fda-for-patients-with-relapsed-or-refractory-multiple-myeloma-who-have-received-at-least-one-prior-line-of-therapy

https://news.bms.com/news/corporate-financial/2024/CHMP-Adopts-Positive-Opinion-Recommending-Approval-of-Bristol-Myers-Squibbs-Opdivo-nivolumab-in-Combination-with-Cisplatin-and-Gemcitabine-for-the-First-Line-Treatment-of-Adult-Patients-with-Unresectable-or-Metastatic-Urothelial-Carcinoma/default.aspx

https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-positive-chmp-opinion-for-rybrevant-amivantamab-in-combination-with-chemotherapy-for-the-first-line-treatment-of-patients-with-advanced-non-small-cell-lung-cancer-with-activating-egfr-exon-20-insertion-mutations

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selpercatinib-ret-fusion-positive-thyroid-cancer

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-mandates-label-updates-car-t-cancer-therapies-2024-06-14/