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Nearly Half of New FDA and EMA Oncology Drug Approvals in Q1 2024 Were Biologics or Biosimilars

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) started 2024 with more than 24 new or expanded indications for previously approved agents and 8 new oncology agents in the first quarter of the year. The approvals were for approximately 14 solid tumor types and 4 hematologic malignancies. Nearly 50% of the approvals were for biologics or biosimilars; there were 14 biologics approved, nearly half of which were programmed cell death protein 1 inhibitors, and 3 biosimilars. Two treatments were approved by both the FDA and the EMA: irinotecan liposome injection (Onivyde®; Ipsen), the first new agent approved for first-line treatment of metastatic pancreatic cancer in more than 10 years, and denosumab (Wyost®; Sandoz) for treatment of bone complications from cancer.

Additional highlights from the first quarter of 2024

  • There were 5 approvals of treatments for non-small cell lung cancer (NSCLC)
  • Pembrolizumab (Keytruda®; Merck Sharp & Dohme) had 3 new approvals: 2 by the FDA and 1 by the EMA
  • 5 products that previously received accelerated approval gained full approval from the FDA
    • Amivantamab-vmjw (Rybrevant®; Janssen Biotech) for NSCLC with epidermal growth factor receptor exon 20 insertion mutations
    • Erdafitinib (Balversa®; Janssen Biotech) for urothelial carcinoma
    • Mirvetuximab soravtansine-gynx (Elahere®; Immunogen/AbbVie) for epithelial ovarian, fallopian tube, or primary peritoneal cancer
    • Tepotinib HCl (Tepmetko®; EMD Serono) for NSCLC
    • Pembrolizumab (Keytruda; Merck) for hepatocellular carcinoma
  • A new granulocyte colony-stimulating factor (G-CSF) biosimilar was approved by the FDA: pegfilgrastim-bmez (Ziextenzo®; Sandoz), for increased survival in patients acutely exposed to myelosuppressive doses of radiation
  • One new G-CSF biologic agent received a positive opinion by the EMA: efbemalenograstim alfa-vuxw (Ryzneuta®; Evive Biotech), for prevention of chemotherapy-induced neutropenia (also approved by the FDA in Q4 2023)
  • The FDA also approved a new artificial intelligence-powered, handheld prescription device for evaluation of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma
  • The FDA added new safety information that pertains to the risk of transplant (including corneal graft) rejection to the labeling for the class of immune checkpoint inhibitors and a boxed warning on all chimeric antigen receptor T-cell therapies regarding risk of T-cell malignancies
  • The FDA withdrew approval of melphalan flufenamide (Pepaxto®; Oncopeptides AB) for treatment of certain patients with multiple myeloma

The tables below summarize key Q1 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
Denosumab (interchangeable biosimilar)
Wyost
Bone
RANKL inhibitor
Sandoz
3/5/24 (FDA) and March 2024 (EMA)b
Irinotecan liposome injection
Onivyde
Pancreatic
Liposomal chemotherapeutic
Ipsen
2/13/24 (FDA) and March 2024 (EMA)b

 

FDA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Alpelisib
Piqray®
Breast cancer
PI3K inhibitor
Novartis
1/18/24
Amivantamab-vmjwc
Rybrevant
NSCLC
Bispecific antibody
Janssen Biotech
3/1/24
Cabazitaxel
Cabazitaxel
Prostate cancer
Microtubule inhibitor
Actavis
3/14/24
Denosumab-bbdz (interchangeable biosimilar)
Jubbonti®
Prostate and breast cancers (to increase bone mass)
RANKL inhibitor
Sandoz
3/5/24
Erdafitinib
Balversa
Urothelial carcinoma
FGFR inhibitor
Janssen Biotech
1/19/24
Inotuzumab ozogamicinc
Besponsa®
ALL
CD22-directed ADC
Wyeth Pharma
3/6/24
Lifileucelc
Amtagvi™
Melanoma
T-cell immunotherapy
Iovance Biotherapeutics
2/16/24d
Lisocabtagene maraleucelc
Breyanzi®
CLL and SLL
CAR T
Bristol Myers Squibb
3/14/24d
Mirvetuximab soravtansine-gynxc
Elahere
Epithelial ovarian, fallopian tube, or primary peritoneal cancer
ADC
Immunogen, Inc (now AbbVie)
3/22/24
Nivolumabc
Opdivo®
Urothelial carcinoma
PD-1 inhibitor
Bristol Myers Squibb
3/6/24
Osimertinib
Tagrisso®
NSCLC
Kinase inhibitor
AstraZeneca
2/16/24
Pegfilgrastim-bmez (biosimilar)
Ziextenzo
Multiple (treated with chemotherapy)
G-CSF
Sandoz
2/28/24
Pembrolizumabc
Keytruda
Cervical cancer
PD-1 inhibitor
Merck
1/12/24
Pembrolizumabc
Keytruda
HCC
PD-1 inhibitor
Merck
1/25/24
Ponatinib HCl
Iclusig®
Ph+ ALL
BCR::ABL1 inhibitor
Takeda Pharmaceuticals
3/19/24d
Talazoparib tosylate
Talzenna®
Breast cancer
PARP inhibitor
Pfizer
3/7/24
Tepotinib HCl
Tepmetko
NSCLC
MET inhibitor
EMD Serono
2/15/24
Tislelizumabc
Tevimbra®
Esophageal squamous cell carcinoma
PD-1 inhibitor
BeiGene
3/13/24
Zanubrutinib
Brukinsa®
Follicular lymphoma
BTK inhibitor
BeiGene
8/14/23

 

EMA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Ciltacabtagene autoleucelc
Carvykti™
Multiple myeloma
CAR T
Janssen-Cilag
February 2024b
Efbemalenograstim alfac
Ryzneuta
Multiple (neutropenia)
G-CSF
Evive Biotech
January 2024b
Enzalutamide
Xtandi®
Prostate cancer
Androgen receptor inhibitor
Astellas Pharma
March 2024b
Idecabtagene vicleucelc
Abecma®
Multiple myeloma
CAR T
Bristol Myers Squibb
January 2024e
Luspaterceptc
Reblozyl®
MDS (anemia)
PD-1 inhibitor
Bristol Myers Squibb
February 2024b
Pembrolizumabc
Keytruda
NSCLC
PD-1 inhibitor
Merck Sharp & Dohme
February 2024b
Retifanlimabc
Zynyz®
Merkel cell carcinoma
PD-1 inhibitor
Incyte
February 2024b
Selpercatinib
Retsevmo®
Thyroid cancer
RET inhibitor
Eli Lilly
January 2024e
Selpercatinib
Retsevmo®
Solid tumors
RET inhibitor
Eli Lilly
March 2024b
Tislelizumabc
Tizveni
NSCLC
PD-1 inhibitor
BeiGene
February 2024b
 

ABL1, ABL proto-oncogene 1; ADC, antibody-drug conjugate; ALL, acute lymphocytic leukemia; BCR, breakpoint cluster region; BTK, Bruton tyrosine kinase; CAR T, chimeric antigen receptor T cell; CLL, chronic lymphocytic leukemia; EMA, European Medicines Agency; FDA, US Food and Drug Administration; FGFR, fibroblast growth factor receptor; G-CSF, granulocyte colony-stimulating factor; HCC, hepatocellular carcinoma; MDS, myelodysplastic syndrome; MET, mesenchymal epithelial transition; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PARP, poly(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; Ph+, Philadelphia chromosome-positive; PI3K, phosphoinositide 3-kinase; RANKL, receptor activator of nuclear factor kappa beta ligand; RET, rearranged during transfection; SLL, small lymphocytic lymphoma.
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
bPositive opinion.
cBiologic.
dAccelerated approval.
eMarketing 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://www.fda.gov/news-events/press-announcements/fda-roundup-january-16-2024

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-requires-boxed-warning-car-t-cancer-therapies-2024-01-23/

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/breyanzi-lisocabtagene-maraleucel

https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-final-decision-withdraw-approval-pepaxto-melphalan-flufenamide?utm_medium=email&utm_source=govdeliveryPepaxto

https://www.fda.gov/news-events/press-announcements/fda-roundup-march-5-2024

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