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New Treatment Options in Oncology: FDA and EMA Drug Approvals in Q3 2022

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved over 30 new oncology agents and new indications for previously approved agents during the third quarter of 2022. One of the main highlights was multiple approvals of the RET inhibitor selpercatinib (Retevmo®; Eli Lilly). Selpercatinib received accelerated approval in the US for second-line treatment of solid tumors and full approval for non-small cell lung cancer (NSCLC). It also received a change to marketing authorization in EMA, with extension of its medullary thyroid cancer indication to first-line use. Another approval of interest was the accelerated approval by the FDA of trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo, AstraZeneca), now the first drug approved for human epidermal growth factor receptor 2 (HER2)-mutant NSCLC. Trastuzumab deruxtecan also received FDA approval for treatment of unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization-negative) breast cancer.

Additional highlights from the third quarter of 2022 include

  • Two Kite Pharma chimeric antigen receptor (CAR) T-cell therapies were approved by the EMA for new indications: axicabtagene ciloleucel (Yescarta®) for treatment of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBCL) and brexucabtagene autoleucel (Tecartus®) for acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL)
  • There were also new indications approved for several other previously approved therapies
    • Crizotinib (Xalkori®; Pfizer) by the FDA for unresectable, recurrent/refractory inflammatory myofibroblastic tumor (IMT) that is anaplastic lymphoma kinase (ALK) positive; by the EMA for pediatric anaplastic large cell lymphoma (ALCL) and IMT
    • Durvalumab (Imfinzi®; AstraZeneca) for biliary tract cancer
    • Niraparib (Zejula®; GlaxoSmithKline) for maintenance treatment of advanced ovarian, fallopian tube, and primary peritoneal cancers
    • Pemigatinib (Pemazyre®; Incyte Corporation) for relapsed/refractory myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 (FGFR1) rearrangement (FDA granted priority review, with breakthrough and orphan designations)
    • Zanubrutinib (Brukinsa®; BeiGene Ireland, Ltd) for marginal zone lymphoma by the EMA
  • Two new biologics for febrile neutropenia received FDA approval: eflapegrastim-xnst (Rolontis®; Spectrum Pharmaceuticals) and pegfilgrastim-fpgk (Stimufend®; Fresenius Kabi USA)
  • There were 2 product indications withdrawn
    • The ovarian cancer indication for olaparib (Lynparza®; AstraZeneca), withdrawn in the US by the manufacturer
    • The EMA recommended that rucaparib camsylate (Rubraca®; Clovis Oncology) no longer be used for third-line ovarian, fallopian tube, or peritoneal cancers, on the basis of results from the ARIEL4 study; it is still approved for use as maintenance treatment following chemotherapy
      • This indication was withdrawn in the US also, in June 2022
    • The other indications of these agents were not affected by the withdrawals
  • Two products previously under accelerated approval received full approval
    • Clofarabine (Clolar®; Genzyme) for treatment of pediatric relapsed/refractory ALL
    • Capmatinib (Tabrecta®; Novartis) for NSCLC with mesenchymal epithelial transition mutation
  • Sodium thiosulfate (Pedmark®, Fennec Pharmaceuticals), approved by the FDA, is the first and only drug approved to reduce the risk of ototoxicity associated with cisplatin in patients 1 month to 19 years old with localized, nonmetastatic solid tumors

The tables below summarize key Q3 oncology approvals:

 

FDA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Acalabrutinib (tablets)
Calquence®
MCL, CLL
TKI
AstraZeneca
8/4/22
Bendamustine HCl
Alkylating agent
Celerity
7/14/22 (tentative)
Bevacizumab-adcd (biosimilar)
Vegzelma®
Colorectal, NSCLC, glioblastoma, RCC, cervical, epithelial ovarian, fallopian tube, peritoneal
Biosimilar referencing Avastin® (Genentech)
Celltrion, Inc.
9/27/22
Bortezomib
Multiple myeloma, MCL
Proteasome inhibitor
Maia Pharmaceuticals
7/27/22
Capmatinib
Tabrecta
NSCLC
MET-targeted kinase inhibitor
Novartis
8/10/22
Clofarabine
Clolar
Pediatric relapsed/refractory ALL
Nucleoside metabolic inhibitor
Genzyme
7/18/22
Crizotinib
Xalkori
IMT
TKI
Pfizer
7/14/22
Darolutamide
Nubeqa®
Prostate cancer
Androgen receptor inhibitor
Bayer HealthCare Pharmaceuticals
8/5/22
Durvalumab
Imfinzi
Biliary tract cancer
PD-L1 blocker
AstraZeneca
9/2/22
Eflapegrastim-xnst (biologic)
Rolontis
Febrile neutropenia
G-CSF
Spectrum Pharmaceuticals
9/9/22
Fam-trastuzumab deruxtecan-nxki
Enhertu
HER2-low breast cancer
HER2-directed antibody-drug conjugate
Daiichi Sankyo
8/5/22
Fam-trastuzumab deruxtecan-nxki
Enhertu
NSCLC with activating HER2 (ERBB2) mutation
HER2-directed antibody-drug conjugate
Daiichi Sankyo
8/11/22b
Futibatinib
Lytgobi®
Cholangiocarcinoma
FGFR inhibitor
Taiho Oncology, Inc.
9/30/22b
Paclitaxel (albumin-bound)
Chemotherapy
Teva
7/15/22 (tentative)
Pegfilgrastim-fpgk
Stimufend
Febrile neutropenia
G-CSF
Fresenius Kabi USA
9/1/22
Pemetrexed disodium
NSCLC, malignant mesothelioma
Folate analog metabolic inhibitor
Accord Healthcare
7/18/22
Pemigatinib
Pemazyre
Myeloid/lymphoid neoplasms with FGFR1 rearrangement
Small-molecule kinase inhibitor
Incyte Corporation
8/26/22
Selpercatinib
Retevmo
Second-line treatment of locally advanced or metastatic solid tumors
RET inhibitor
Eli Lilly and Company
9/21/22
Selpercatinib
Retevmo
NSCLC with RET gene fusion
RET inhibitor
Eli Lilly and Company
9/21/22
Sodium thiosulfate
Pedmark
Cisplatin-related ototoxicity in pediatric patients
Antidote
Fennec Pharmaceuticals
9/20/22

 

 

EMA Approvals
Generic Name
Brand Name
Tumor Typea
MOA
Manufacturer
Approval
Axicabtagene ciloleucel
Yescarta
DLBCL and HGBCL
CAR T-cell therapy
Kite Pharma EU
September 2022
Brexucabtagene autoleucel
Tecartus
ALL
CAR T-cell therapy
Kite Pharma EU
July 2022
Brexucabtagene autoleucel
Tecartus
MCL
CAR T-cell therapy
Kite Pharma EU
August 2022c
Crizotinib
Xalkori
ALCL or IMT
Kinase inhibitor
Pfizer Europe MA EEIG
September 2022
Doxorubicin HCl
Celdoxome pegylated liposomal
Breast cancer, ovarian cancer, multiple myeloma, Kaposi sarcoma
Chemotherapy
YES Pharma
July 2022d
Loncastuximab tesirine
Zynlonta®
DLBCL and HGBCL
Monoclonal antibody-drug conjugate
ADC Therapeutics
September 2022c
Relatlimab-nivolumab
Opdualag™
Advanced melanoma
I-O: PD-1–blocking and LAG-3–blocking antibodies
Bristol Myers Squibb Pharma
July 2022d
Selpercatinib
Retsevmo®
Medullary thyroid cancer
RET inhibitor
Eli Lilly Nederland
July 2022
Sorafenib
Sorafenib Accord (generic)
Hepatocellular and renal cell carcinoma
Protein kinase inhibitor
Accord Healthcare
September 2022d
Teclistamab
Tecvayli®
Multiple myeloma
Bispecific antibody (targets BCMA and CD3)
Janssen-Cilag International
July 2022c
Thalidomide
Thalidomide Lipomed (generic)
Multiple myeloma
Hybrid medicine
Lipomed GmbH
July 2022
Zanubrutinib
Brukinsa
Marginal zone lymphoma
BTK inhibitor
BeiGene Ireland Ltd
September 2022d
aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
bAccelerated approval.
cConditional marketing authorization.
dPositive opinion.
ALCL, anaplastic large cell lymphoma; ALL, acute lymphocytic leukemia; BCMA, B-cell maturation antigen; BTK, Bruton tyrosine kinase; CAR, chimeric antigen receptor; CD3, cluster of differentiation 3; CLL, chronic lymphocytic leukemia; DLBCL, diffuse large B-cell lymphoma; ERBB2, erb-b2 receptor tyrosine kinase 2; FDA, US Food and Drug Administration; FGFR, fibroblast growth factor receptor; G-CSF, granulocyte colony-stimulating factor; HER2, human epidermal growth factor receptor 2; HGBCL, high grade B-cell lymphoma; IMT, inflammatory myofibroblastic tumor; I-O, immuno-oncology; LAG-3, lymphocyte activation gene 3; MCL, mantle cell lymphoma; MET, mesenchymal-epithelial transition; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; PD-L1, programmed cell death protein 1 ligand 1; RCC, renal cell carcinoma; RET, rearranged during transfection; 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-18-21-july-2022

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-september-2022 

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