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New Treatment Options in Oncology FDA and EMA Drug Approvals in Q4 2021

New Treatment Options in Oncology: FDA and EMA Drug Approvals in Q1 2022

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 25 new oncology agents and new indications during the first few months of 2022. One of the main highlights was the approval of tebentafusp-tebn (Kimmtrak®; Immunocore Ltd.) by both agencies. Tebentafusp-tebn is the first and only FDA-approved therapy for unresectable or metastatic uveal melanoma, and the first T-cell receptor therapeutic to receive regulatory approval. Chimeric antigen receptor T-cell (CAR T) therapy ciltacabtagene autoleucel (Carvykti®; Janssen Biotech) was also approved by both agencies.

There were 2 product indication withdrawals in the US by the manufacturers: the gastric cancer indication for pembrolizumab (Keytruda®; Merck) and the follicular lymphoma and small lymphocytic leukemia indications for idelalisib (Zydelig®; Gilead).

Additional highlights from the first quarter of 2022 include

  • Two CAR T-cell therapies were approved through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines
    • Lisocabtagene maraleucel (Breyanzi®; Bristol Myers Squibb) received EMA positive recommendation
    • Ciltacabtagene autoleucel (Carvykti; Janssen Biotech) received conditional marketing authorization
  • Nivolumab + ipilimumab (Opdivo® + Yervoy®; Bristol Myers Squibb) received a new indication for esophageal squamous cell carcinoma
  • EMA readopted its opinion of enfortumab vedotin (Padcev®; Astellas Pharma) for treatment of urothelial cancer, following further safety information
  • Pembrolizumab (Keytruda; Merck) received approval for patients with cervical cancer and those with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors, including
  • Unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy
  • Advanced or recurrent endometrial carcinoma with disease progression on or following prior treatment with a platinum-containing therapy and that is not a candidate for curative surgery or radiation
  • Unresectable or metastatic gastric, small intestine, or biliary cancer, with disease progression on or following at least 1 prior therapy
  • The VENTANA MMR RxDx Panel (F. Hoffman-La Roche) was also approved by the EMA as a companion diagnostic device to select patients with dMMR in solid tumors that are eligible for treatment with pembrolizumab
  • There were 3 approvals for prostate cancer
    • The FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto®; Novartis), a search-and-destroy radioactive medicine that works by detecting the presence of prostate-specific membrane antigen (PSMA) on cancerous cells anywhere in the body and delivering energy emissions from the radioisotope to destroy the target cells
      • The FDA approved a complementary diagnostic imaging agent, gallium Ga 68 gozetotide (Locametz®), also produced by Novartis
    • The EMA approved relugolix (Orgovyx®; Myovant Sciences) and leuprolide mesylate (Camcevi®; Accord BioPharma), a hybrid medicine of Eligard® (leuprolide acetate)
  • Two new treatments for early breast cancer were approved
    • FDA: olaparib (Lynparza®; AstraZeneca)
    • EMA: abemaciclib (Verzenio®; Eli Lilly and Company)
  • Two new biosimilars for neutropenia were approved: filgrastim-ayow (Releuko®; Kashiv Biosciences), by the FDA, and pegfilgrastim (Stimufend®; Fresenius Kabi Deutschland GmbH), by the EMA

The tables below summarize key Q1 oncology approvals:

 

FDA and EMA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Ciltacabtagene autoleucel
Ciltacabtagene autoleucel
Multiple myeloma
CAR T therapy
Janssen Biotech, Inc
1/28/22 (FDA)
3/1/22 (EMA)
Tebentafusp-tebn
Kimmtrak
Uveal melanoma
T-cell engager
Immunocore Ltd.
January (FDA)
February 2022 (EMA)

 

FDA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manu-facturer
Approval
Filgrastim-ayow (biosimilar)
Releuko
Supportive care: neutropenia
Leukocyte growth factor
Kashiv Biosciences
2/25/22
Lutetium Lu 177 vipivotide tetraxetan
Pluvicto
Prostate cancer
PSMA-targeted radioligand therapy
Novartis
3/23/22
Nivolumab
Opdivo + platinum-doublet chemotherapy
NSCLC
PD-1 inhibitor
Bristol Myers Squibb
3/4/22
Nivolumab and relatlimab-rmbw (biologic)
Opdualag™
Melanoma
PD-1 inhibitor and LAG-3 blocker
Bristol Myers Squibb
3/18/22
Olaparib
Lynparza
Early breast cancer
PARP inhibitor
AstraZeneca
3/11/22
Pembrolizumab
Keytruda
Endometrial carcinoma
PD-1 inhibitor
Merck
3/21/22

EMA Approvals
Generic Name
Brand Name
Indication
MOA
Manufacturer
Approval
Abemaciclib
Verzenio
Early breast cancer
CDK4/6 inhibitor
Eli Lilly and Company
February 2022
Avapritinib
Ayvakyt
Advanced systemic mastocytosis
KIT D816V inhibitor
Blueprint Medicines
January 2022
Cabozantinib
Cabometyx®
Differentiated thyroid carcinoma
Multitargeted TKI
Ipsen
March 2022
Dasatinib (generic)
Dasatinib Accord, Dasatinib Accordpharma
Leukemia
TKI
Accord Healthcare
January 2022
Enfortumab vedotin
Padcev
Urothelial cancer
Antibody-drug conjugate
Astellas Pharma
February 2022
Leuprolide mesylate
Camcevib
Prostate cancer
GnRH agonist
Accord Healthcare
March 2022
Lisocabtagene maraleucel
Breyanzi
Lymphoma
CAR T-cell therapy
Bristol Myers Squibb
January 2022
Nivolumab
Opdivo
Muscle-invasive urothelial carcinoma
PD-1 inhibitor
Bristol Myers Squibb
February 2022
Nivolumab
Opdivo + fluoropyrimidine- and platinum-based combination chemotherapy
Esophageal squamous cell carcinoma
PD-1 inhibitor
Bristol Myers Squibb
February 2022
Nivolumab + ipilimumab
Opdivo + Yervoy
Esophageal squamous cell carcinoma
PD-1 inhibitor
Bristol Myers Squibb
February 2022
Pegfilgrastim (biosimilar)
Stimufend
Neutropenia
rG-CSF
Fresenius Kabi
March 2022
Pegylated liposomal doxorubicin
Zolsketilc
Breast, ovarian, multiple myeloma, AIDS-related Kaposi sarcoma
Chemotherapy
Accord Healthcare
March 2022
Pembrolizumab
Keytruda
MSI-H or dMMR tumors
PD-1 inhibitor
Merck
March 2022
Pembrolizumab
Keytruda
Cervical cancer
PD-1 inhibitor
Merck
March 2022
Polatuzumab vedotin
Polivy™
Large B-cell lymphoma
CD79b-directed antibody-drug conjugate
Roche
March 2022
Relugolix
Orgovyx
Prostate cancer
Hormone antagonist
Myovant Sciences
February 2022
Tisagenlecleucel
Kymriah
Follicular lymphoma
T-cell immunotherapy
Novartis
March 2022
CD79b, cluster of differentiation 79b; CDK4/6, cyclin-dependent kinase 4 and 6; GnRH, gonadotropin-releasing hormone; LAG-3, lymphocyte-activation gene 3; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PARP, poly(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PSMA, prostate-specific membrane antigen; rG-CSF, recombinant human granulocyte colony-stimulating factor; TKI, tyrosine kinase inhibitor.
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
bHybrid medicine of Eligard (leuprolide acetate).
cHybrid medicine of Adriamycin® (doxorubicin), bioequivalent to Caelyx (pegylated liposomal doxorubicin HCl).

 

 

Sources:

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-january-2022
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-february-2022
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-march-2022
https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications
https://www.oncology-central.com/top-3-cancer-drug-approvals-january-2022/
https://www.oncology-central.com/top-3-drug-approvals-in-oncology-in-march-2022-sotorasib-opdualag-and-pluvicto/

 

 

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