Lutetium (177Lu) vipivotide tetraxetan

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Lutetium (177Lu) vipivotide tetraxetan
Names
Trade namesPluvicto
Other names177Lu-PSMA-617, Lutetium Lu 177 vipivotide tetraxetan (USAN US)
Clinical data
Drug classRadiopharmaceutical
Main usesProstate cancer[1]
Side effectsTiredness, dry mouth, nausea, low hemoglobin, decreased appetite, constipation[1]
Routes of
use
Intravenous
Legal
License data
Legal status
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 radioactive medication used to treat metastatic castration-resistant prostate cancer (mCRPC) that is prostate-specific membrane antigen (PSMA)-positive.[1] It is given by injection into a vein.[4]

Common side effects include tiredness, dry mouth, nausea, low hemoglobin, decreased appetite, and constipation.[1] Other side effects may include radiation exposure, bone marrow suppression, infertility, and kidney problems.[1] Use by males with pregnant partners may harm the baby.[1] Vipivotide tetraxetan binds to PSMA-expressing tumor cells while the attached 177Lu destroys the cells by beta particle radiation.[4]

Lutetium (177Lu) vipivotide tetraxetan was approved for medical use in the United States in 2022.[1] In October 2022, Europe recommended its approval.[5] In the United States it costs about 45,000 USD per dose as of 2022.[6]

Medical uses

Dosage

It is generally give at a dose of 7.4 GBq (200 mCi) every 6 weeks for up to a total of 6 doses plus BSoC or BSoC alone.[3]

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[7] and Endocyte itself was acquired by Novartis in 2018.[8]

Efficacy was evaluated in VISION,[9] 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]

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

Legal status

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.[10] The applicant for this medicinal product is Novartis Europharm Limited.[10]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "Pluvicto- lutetium lu 177 vipivotide tetraxetan injection, solution". DailyMed. 23 March 2022. Archived from the original on 5 April 2022. Retrieved 4 April 2022.
  2. Advanced Accelerator Applications USA. "Pluvicto Product Monograph" (PDF). The Drug and Health Product Register. Government of Canada. Archived (PDF) from the original on 1 October 2022. Retrieved 12 October 2022.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 "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. 4.0 4.1 "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.
  5. "Pluvicto: Pending EC decision - European Medicines Agency". European Medicines Agency. 2022-10-13. Archived from the original on 2022-10-14. Retrieved 2022-10-13.
  6. "Pluvicto Prices, Coupons, Copay & Patient Assistance". Drugs.com. Retrieved 12 December 2022.
  7. "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 2022-04-13.
  8. Taylor, Nick Paul (2018-10-18). "Novartis inks $2.1B Endocyte buyout, furthering radiotherapy push". Fierce Biotech. Archived from the original on 30 November 2020. Retrieved 2022-04-13.
  9. Clinical trial number NCT03511664 for "Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)" at ClinicalTrials.gov.
  10. 10.0 10.1 "Pluvicto: Pending EC decision". European Medicines Agency (EMA). 13 October 2022. Archived from the original on 14 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.

External links

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