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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 Q4 2021

There were several approvals of new oncology agents and new indications during the final months of 2021 by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). One of the main highlights is that immunotherapy, particularly checkpoint inhibitor therapy, continues to expand, with multiple new approvals in the fourth quarter. Programmed cell death protein 1 ligand 1 (PD-L1) inhibitor pembrolizumab (Keytruda®) received EMA approval for treatment of triple-negative breast cancer, renal cell carcinoma, and in combination with lenvatinib (Lenvima® [US]/Kisplyx® [EU]) for treatment of renal cell carcinoma and endometrial carcinoma. Pembrolizumab also received FDA approval in 4 new indications, including use as single-agent or combination therapy for patients with recurrent or metastatic cervical cancer, pediatric melanoma, and renal cell carcinoma. Another PD-L1 inhibitor, atezolizumab (Tecentriq®), received FDA approval for treatment of non-small cell lung cancer in October.

Additional points of interest include

  • Six new treatments were approved for non-small cell lung cancer: amivantamab (Rybrevant®; FDA approval), atezolizumab (Tecentriq; FDA approval), lorlatinib (Lorviqua®; EMA approval), pralsetinib (Gavreto®; EMA approval), sotorasib (Lumykras®; EMA approval), and tepotinib (Tepmetko®; EMA approval)
  • Several of the new approvals are treatments for hematologic malignancies: brexucabtagene autoleucel (Tecartus®; acute lymphoblastic leukemia), asciminib (Scemblix®; chronic myeloid leukemia), rituximab (Rituxan®; pediatric lymphomas), and daratumumab + hyaluronidase-fihj and carfilzomib + dexamethasone (Darzalex Faspro® + Kyprolis® + dexamethasone; multiple myeloma)
  • Three new treatments were approved for breast cancer: abemaciclib (Verzenio®; FDA approval), pembrolizumab (Keytruda®; EMA approval for triple-negative breast cancer), and sacituzumab govitecan (Trodelvy®; EMA positive opinion for triple-negative breast cancer)
  • A bevacizumab biosimilar, Mvasi®, was approved by the FDA for ovarian, fallopian tube, or primary peritoneal cancers
  • Many newly approved products (eg, atezolizumab, abemaciclib, lorlatinib, pralsetinib, sotorasib, tepotinib) target specific genetic mutations, leading to simultaneous approvals of accompanying diagnostics. For example, the Ventana PD-L1 Assay was approved as a companion diagnostic device with atezolizumab
  • A new diagnostic imaging agent, Cytalux™ , was approved for identifying ovarian cancers

The tables below summarize key Q4 approvals:

FDA and EMA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manu-facturer
Approval
Pembrolizumab
Keytruda
Renal cell carcinoma
PD-L1 inhibitor
Merck
November (FDA) and December 2021 (EMA)
MOA, mechanism of action.
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.

 

 

FDA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manu-facturer
Approval
Abemaciclib
Verzenio
Breast cancer
CDK4/6 inhibitor
Eli Lilly and Company
October 2021
Asciminib
Scemblix
Chronic myeloid leukemia
STAMP inhibitor
Novartis AG
October 2021
Atezolizumab
Tecentriq
Non-small cell lung cancer
PD-L1 inhibitor
Genentech, Inc
October 2021
Bevacizumab
Mvasi
Ovarian, fallopian tube, or primary peritoneal cancer
(Biosimilar)
Amgen, Inc
November 2021
Brexucabtagene autoleucel
Tecartus
Acute lymphoblastic leukemia
CAR T-cell therapy
Kite Pharma, Inc
October 2021
Daratumumab + hyaluronidase-fihj and carfilzomib + dexamethasone
Darzalex Faspro + Kyprolis + dexamethasone
Multiple myeloma
Janssen Biotech, Inc and Amgen, Inc
November 2021
Pafolacianine
Cytalux™
Ovarian
Optical imaging agent
On Target Laboratories
November 2021
Pembrolizumab
Keytruda
Cervical cancer
PD-L1 inhibitor
Merck
October 2021
Pembrolizumab
Keytruda
Melanoma
PD-L1 inhibitor
Merck
December 2021
Rituximab + chemotherapy
Rituxan
Pediatric lymphoma
Monoclonal antibody
Genentech, Inc
December 2021
Sirolimus protein-bound particles for injectable suspension
Fyarro™
Perivascular epithelioid cell tumor
mTOR inhibitor
Aadi Bioscience, Inc
November 2021
CAR, chimeric antigen receptor; CDK4/6, cyclin-dependent kinase 4/6; mTOR, mechanistic target of rapamycin; STAMP, specifically targeting the ABL myristoyl pocket.
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.

 

 

EMA Approvals
Generic Name
Brand Name
Indication
MOA
Manu-facturer
Approval
Amivantamab
Rybrevant
Non-small cell lung cancer
Fully human, bispecific antibody
Janssen-Cilag International N.V.
Conditional marketing authorization October 2021
Enfortumab vedotin
Padcev®
Urothelial cancer
Antibody-drug conjugate
Astellas Pharma Europe B.V.
Positive opinion December 2021
Lorlatinib
Lorviqua
Non-small cell lung cancer
ALK and ROS1 inhibitor
Pfizer
Positive opinion December 2021
Pembrolizumab
Keytruda
Triple-negative breast cancer
PD-L1 inhibitor
Merck
October 2021
Pembrolizumab + lenvatinib
Keytruda + Kisplyx
Renal cell carcinoma and endometrial carcinoma
PD-L1 inhibitor + TKI
Merck and Eisai
Positive opinion October 2021
Pralsetinib
Gavreto
Non-small cell lung cancer
RET inhibitor
Roche
Conditional marketing approval November 2021
Sacituzumab govitecan
Trodelvy
Triple-negative breast cancer
Trop-2–directed antibody and topoisomerase inhibitor conjugate
Gilead
Positive opinion October 2021
Sotorasib
Lumykras (EU)
Non-small cell lung cancer
KRASG12C inhibitor
Amgen
Positive opinion November 2021
Tegafur/gimeracil/oteracil
Teysuno®
Colorectal cancer
Antimetabolite
Nordic Group
Positive opinion December 2021
Tepotinib
Tepmetko
Non-small cell lung cancer
MET inhibitor
Merck
Positive opinion December 2021
ALK, anaplastic lymphoma kinase; TKI, tyrosine kinase inhibitor.

 

Sources:

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications?t=308050

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-october-2021

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-8-11-november-2021

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021

 

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