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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 Q2 2023 – Focus on DLBCL, NSCLC, and Biologics

In the second quarter of 2023, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved more than 21 new oncology agents and new indications for previously approved agents. The cancer types with the most approvals were diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma and non-small cell lung cancer (NSCLC). There were 5 diagnostic agents, 8 biologics, 3 programmed cell death protein 1 inhibitors, and 4 antibody-drug conjugates approved. One treatment, glofitamab-gxbm (Columvi™; Genentech/Roche), was approved by both the FDA and the EMA for treatment of DLBCL.

 

Additional highlights from the second quarter of 2023 include

  • 2 previous accelerated approval products received full approval by the FDA: blinatumomab (Blincyto®; Amgen) for adult and pediatric B-lymphocyte antigen CD19-positive B-cell precursor acute lymphoblastic leukemia; and polatuzumab vedotin-piiq (Polivy®; Genentech) with bendamustine and a rituximab product for relapsed/refractory DLBCL, not otherwise specified (NOS)
  • 3 product indications were expanded with new approvals by the EMA
    • Nivolumab (Opdivo®; Bristol-Myers Squibb) melanoma indications were expanded to include pediatric patients aged 12 and older
    • Ipilimumab (Yervoy®; Bristol-Myers Squibb) expanded from monotherapy indication to approval for use in combination with nivolumab for treatment of melanoma
    • Sacituzumab govitecan (Trodelvy®; Gilead Sciences Ireland) for unresectable or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, in addition to its previous indication for triple-negative breast cancer
  • 4 new diagnostics were approved by the FDA
    • Flotufolastat F 18 (Posluma®; Blue Earth Diagnostics), a radioactive diagnostic agent approved by the FDA for positron emission tomography of prostate-specific membrane antigen-positive lesions in men with prostate cancer
    • Indocyanine green for injection (Spy Agent® Green; Novadaq Tech) for visualization of lymph nodes and lymphatic vessels during lymphatic mapping in adults with breast cancer
    • Iopromide (Ultravist® [-300, -370]; Bayer) for contrast-enhanced mammography
    • FoundationOne® Liquid CDx (Foundation Medicine), for diagnosing metastatic colorectal cancer with B-Raf proto-oncogene V600E alteration as a companion diagnostic for encorafenib (Braftovi®; Pfizer)
  • 1 new diagnostic was approved by the EMA: piflufolastat (18F) (Pylclari®; Curium Pet France) for prostate cancer diagnosis
  • Under its Project Orbis initiative, the FDA granted accelerated approval for glofitamab-gxbm (Columvi™; Genentech) to treat relapsed or refractory DLBCL, NOS or large B-cell lymphoma arising from follicular lymphoma, in collaboration with Switzerland’s Swissmedic
  • 2 indications for ibrutinib (Imbruvica®; Pharmacyclics) were removed by the FDA
  • Mantle cell lymphoma after at least 1 prior therapy
  • Marginal zone lymphoma after at least 1 prior anti–B-lymphocyte antigen CD20–based therapy
  • The EMA application for ivosidenib (Tidhesco®; Les Laboratoires Servier) in acute myeloid leukemia was withdrawn after receiving positive opinion in February 2023, because the application was a duplicate of Tibsovo® (Les Laboratoires Servier)
  • The pralsetinib (Gavreto®; Genentech) indication for Ret proto-oncogene–mutant medullary thyroid cancer was also removed by the FDA (pralsetinib had previously received prior approval)

The tables below summarize key Q2 2023 oncology approvals:

FDA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Blinatumomab
Blincyto
ALL
CD19-directed CD3 T-cell engager
Amgen
6/20/23
Enfortumab vedotin-ejfv + pembrolizumab
Padcev
Urothelial carcinoma
Nectin-4–directed ADC
Astellas Pharma
4/03/23
Epcoritamab-byspb
Epkinly
DLBCL, HGBCL
Bispecific CD20-directed CD3 T-cell engager
Genmab US
5/19/23
Flotufolastat F 18
Posluma
Prostate cancer (diagnostic)
Radioactive diagnostic agent
Blue Earth Diagnostics
5/25/23
Glofitamab-gxbmb
Columvi
DLBCL, NOS or LBCL arising from FL
T-cell–engaging bispecific antibody
Genentech
6/15/23c
Indocyanine green
Spy Agent Green
Breast cancer (diagnostic)
Diagnostic agent
Novadaq Tech
6/05/23
Iopromide
Ultravist (-300, -370)
Breast cancer (diagnostic)
Iodine-based contrast agent
Bayer
5/25/23
Niraparib
Zejula
Epithelial ovarian, fallopian tube, primary peritoneal (advanced and BRCA-mutated indications)
PARP inhibitor
GlaxoSmithKline
4/26/23
Olaparib
Lynparza
BRCA-mutated CRPC
PARP inhibitor
AstraZeneca
5/31/23
Omidubicelb
Omisirge
Hematologic malignancies
Cryopreserved nicotinamide-modified allogeneic hematopoietic progenitor cell therapy
Gamida Cell
4/17/23
Pembrolizumabb
Keytruda
Urothelial carcinoma
PD-1 inhibitor
Merck
4/03/23
Pemetrexed
Pemetrexed injection
NSCLC
Antifolate
Shilpa Medicare
5/22/23
Polatuzumab vedotin-piiqb
Polivy
(with R-CHP) DLBCL, NOS and HGBCL
CD79b-directed ADC
Genentech
4/19/23
Polatuzumab vedotin-piiqb
Polivy
(with bendamustine and a rituximab product) DLBCL, NOS and HGBCL
CD79b-directed ADC
Genentech
4/19/23
Polyethylene glycol 3350; sodium sulfate; potassium chloride; magnesium sulfate; sodium chloride)
Suflave
Cleansing of the colon
Colonoscopy prep
Braintree Labs
6/15/23
Talazoparib
Talzenna
Metastatic CRPC
PARP inhibitor
Pfizer
6/20/23
FoundationOne Liquid CDx
CRC (diagnostic)
Diagnostic agent
Foundation Medicine
6/9/23

 

   

EMA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Futibatinib
Lytgobi
Cholangiocarcinoma
FGFR inhibitor
Taiho Pharma
April 2023d
Glofitamab-gxbmb
Columvi
DLBCL, NOS or LBCL arising from FL
T-cell–engaging bispecific antibody
Roche
April 2023d
Ivosidenib
Tibsovo
AML and cholangiocarcinoma
IDH1 inhibitor
Les Laboratoires Servier
May 2023
Nivolumab
Opdivo
Melanoma (pediatric)
PD-1 inhibitor
Bristol-Myers Squibb
April 2023
Nivolumab
Opdivo
NSCLC (neoadjuvant)
PD-1 inhibitor
Bristol-Myers Squibb
May 2023d
Piflufolastat (18F)
Pylclari
Prostate cancer (diagnostic)
Diagnostic radiopharmaceutical
Curium Pet France
May 2023
Pirtobrutinib
Jaypirca
MCL
TBK inhibitor
Eli Lilly
April 2023d
Sacituzumab govitecan-hziyb
Trodelvy
Breast cancer
ADC
Gilead Sciences, Ireland
June 2023d
Tremelimumab-actl
Imjudo
NSCLC
Anti–CTLA-4 antibody
AstraZeneca
June 2023d
Trifluridine/tipiracil
Lonsurf
CRC
Thymidine-based nucleoside analog and thymidine phosphorylase inhibitor
Les Laboratoires Servier
June 2023d
Ipilimumab
Yervoy
(In combination with nivolumab) melanoma
CTLA-4 immune checkpoint inhibitor
Bristol-Myers Squibb
April 2023
 

ADC, antibody-drug conjugate; ALL, acute lymphocytic leukemia; AML, acute myeloid leukemia; BRCA, breast cancer gene; CD19, B-lymphocyte antigen CD19; CD20, B-lymphocyte antigen CD20; CD70B, cluster of differentiation 79B; CRC, colorectal cancer; CRPC, castration-resistant prostate cancer; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; DLBCL, diffuse large B-cell lymphoma; EMA, European Medicines Agency; FDA, US Food and Drug Administration; FGFR, fibroblast growth factor receptor; FL, follicular lymphoma; HGBCL, high-grade B-cell lymphoma; IDH1, isocitrate dehydrogenase 1; LBCL, large B-cell lymphoma; MCL, mantle cell lymphoma; MOA, mechanism of action; NOS, not otherwise specified; NSCLC, non-small cell lung cancer; PARP, poly(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PET, positron emission tomography; R-CHP, rituximab, cyclophosphamide, doxorubicin, and prednisone; TBK, TANK-binding kinase.
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
bBiologic.
cAccelerated approval.
dPositive opinion.

 

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

https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights

https://www.prnewswire.com/news-releases/servier-receives-european-commission-approval-of-tibsovo-ivosidenib-tablets-in-idh1-mutated-acute-myeloid-leukemia-and-idh1-mutated-cholangiocarcinoma-301820895.html

https://www.reuters.com/business/healthcare-pharmaceuticals/genentech-withdraws-use-gavreto-us-type-thyroid-cancer-says-partner-blueprint-2023-06-30/

 

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