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Lutetium (177Lu) vipivotide tetraxetan

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Lutetium (177Lu) vipivotide tetraxetan
Clinical data
Trade namesPluvicto
Other names177Lu-PSMA-617, Lutetium Lu 177 vipivotide tetraxetan (USAN US)
License data
Routes of
administration		Intravenous
Drug classRadiopharmaceutical
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
Chemical and physical data
3D model (JSmol)
  • [177Lu+3].OC(=O)CC[C@H](NC(=O)N[C@@H](CCCCNC(=O)[C@H](Cc1ccc2ccccc2c1)NC(=O)[C@@H]3CC[C@@H](CNC(=O)CN4CCN(CC(=O)[O-])CCN(CC(=O)[O-])CCN(CC(=O)[O-])CC4)CC3)C(=O)O)C(=O)O
  • InChI=1S/C49H71N9O16.Lu/c59-40(28-55-17-19-56(29-42(62)63)21-23-58(31-44(66)67)24-22-57(20-18-55)30-43(64)65)51-27-32-8-12-35(13-9-32)45(68)52-39(26-33-10-11-34-5-1-2-6-36(34)25-33)46(69)50-16-4-3-7-37(47(70)71)53-49(74)54-38(48(72)73)14-15-41(60)61;/h1-2,5-6,10-11,25,32,35,37-39H,3-4,7-9,12-24,26-31H2,(H,50,69)(H,51,59)(H,52,68)(H,60,61)(H,62,63)(H,64,65)(H,66,67)(H,70,71)(H,72,73)(H2,53,54,74);/q;+3/p-3/t32-,35-,37-,38-,39-;/m0./s1/i;1+2
  • Key:RSTDSVVLNYFDHY-BGOLSCJMSA-K

Lutetium (177Lu) vipivotide tetraxetan, sold under the brand name Pluvicto, is a radiopharmaceutical medication used for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).[2][3] Lutetium (177Lu) vipivotide tetraxetan is a targeted radioligand therapy.[3][4]

The most common adverse reactions include fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation.[3]

Lutetium (177Lu) vipivotide tetraxetan is a radioconjugate composed of PSMA-617, a human prostate-specific membrane antigen (PSMA)-targeting ligand, conjugated to the beta-emitting radioisotope lutetium-177, with potential antineoplastic activity against PSMA-expressing tumor cells.[5] Upon intravenous administration of lutetium (177Lu) vipivotide tetraxetan, vipivotide tetraxetan targets and binds to PSMA-expressing tumor cells.[5] Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of beta particle radiation.[5] PSMA, a tumor-associated antigen and type II transmembrane protein, is expressed on the membrane of prostatic epithelial cells and overexpressed on prostate tumor cells.[5]

Lutetium (177Lu) vipivotide tetraxetan was approved for medical use in the United States in March 2022.[3][6]

In October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of Pluvicto to treat prostate cancer in the European Union.[7]

History

The medication was developed by German Cancer Research Center and University Hospital Heidelberg and licensed to the small German pharmaceutical company ABX for early clinical development. In 2017 the license was acquired by Endocyte[8] and Endocyte itself was acquired by Novartis in 2018.[9]

Efficacy was evaluated in VISION,[10] a randomized (2:1), multicenter, open-label trial that evaluated lutetium (177Lu) vipivotide tetraxetan plus best standard of care (BSoC) (n=551) or BSoC alone (n=280) in men with progressive, prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).[3] All participants received a GnRH analog or had prior bilateral orchiectomy.[3] Participants were required to have received at least one androgen receptor pathway inhibitor, and 1 or 2 prior taxane-based chemotherapy regimens.[3] Participants received lutetium (177Lu) vipivotide tetraxetan 7.4 GBq (200 mCi) every 6 weeks for up to a total of 6 doses plus BSoC or BSoC alone.[3]

The U.S. Food and Drug Administration (FDA) granted the application for lutetium (177Lu) vipivotide tetraxetan priority review and breakthrough therapy designations.[3]

Society and culture

On 13 October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pluvicto, intended for the treatment of prostate cancer.[11] The applicant for this medicinal product is Novartis Europharm Limited.[11]

References

  1. ^ Advanced Accelerator Applications USA. "Pluvicto Product Monograph" (PDF). The Drug and Health Product Register. Government of Canada. Retrieved 12 October 2022.
  2. ^ a b "Pluvicto- lutetium lu 177 vipivotide tetraxetan injection, solution". DailyMed. 23 March 2022. Archived from the original on 5 April 2022. Retrieved 4 April 2022.
  3. ^ a b c d e f g h i j "FDA approves Pluvicto for metastatic castration-resistant prostate can". U.S. Food and Drug Administration. 23 March 2022. Archived from the original on 24 March 2022. Retrieved 23 March 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ Neels OC, Kopka K, Liolios C, Afshar-Oromieh A (December 2021). "Radiolabeled PSMA Inhibitors". Cancers. 13 (24): 6255. doi:10.3390/cancers13246255. PMC 8699044. PMID 34944875.
  5. ^ a b c d "Lutetium Lu 177 Vipivotide Tetraxetan (Code C148145)". NCI Thesaurus. 28 February 2022. Archived from the original on 15 April 2022. Retrieved 23 March 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ "Novartis Pluvicto approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer" (Press release). Novartis. 23 March 2022. Archived from the original on 23 March 2022. Retrieved 23 March 2022.
  7. ^ "Pluvicto: Pending EC decision - European Medicines Agency". European Medicines Agency. 13 October 2022. Retrieved 13 October 2022.
  8. ^ "Endocyte Announces Exclusive License of Phase 3 Ready PSMA-Targeted Radioligand Therapy for Development in Prostate Cancer". www.isotope.com. Archived from the original on 29 April 2019. Retrieved 13 April 2022.
  9. ^ Taylor, Nick Paul (18 October 2018). "Novartis inks $2.1B Endocyte buyout, furthering radiotherapy push". Fierce Biotech. Archived from the original on 30 November 2020. Retrieved 13 April 2022.
  10. ^ Clinical trial number NCT03511664 for "Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)" at ClinicalTrials.gov.
  11. ^ a b "Pluvicto: Pending EC decision". European Medicines Agency (EMA). 13 October 2022. Retrieved 14 October 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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