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/