Evidence map›Paper›PMID 37212825›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.

Asma Dilawari, Mirat Shah, Gwynn Ison, Haley Gittleman, Mallorie H Fiero, Ankit Shah, Salaheldin S Hamed, Junshan Qiu, Jingyu Yu, Wimolnut Manheng and 15 more

Registry-linked trialOpen access · greenAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04296890 (SORAYA), which is not on this map. Cited by 73 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 1 pooled it
26.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04296890 phase3completednot on this map

SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

TypeinterventionalSponsorImmunoGen, Inc.Ran2020 to 2022Enrolled106ConditionsEpithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube CancerArmsMirvetuximab Soravtansine
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 1 synthesis or guideline pooled it, 97 citations in OpenAlex.

  1. Pooled it
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  15. Ovarian cancer.Nature reviews. Disease primers · 2026
    Review
  16. Article
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  18. Article
  19. Review
  20. Review

13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 3 institutions in 1 country.

Asma Dilawari *Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-5706-9138
Mirat Shah *Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-0052-9978
Gwynn IsonCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0009-0005-7228-7885
Haley GittlemanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-6976-8777
Mallorie H FieroCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-5536-116X
Ankit ShahCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-9771-8777
Salaheldin S HamedCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0009-0009-7675-3088
Junshan QiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-3629-1703
Jingyu YuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0009-0006-6249-7907
Wimolnut ManhengCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-3909-086X
Tiffany K RicksCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-2026-0996
Rajan PraganiCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0009-0004-9401-7811
Arulvathani ArudchandranCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0009-0003-7563-0496
Paresma PatelCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-7121-858X
Shadia ZamanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-6371-0032
Arpita RoyCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-0268-9772
Shyam KalavarCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-7280-7132
Soma GhoshCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0003-0935-1141
William F PierceCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-3411-7720
Nam Atiqur RahmanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0009-0001-0002-7006
Shenghui TangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-0437-665X
Bronwyn D MixterOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-5277-4399
Paul G KluetzOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-9796-4791
Richard PazdurOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-4771-9923
Laleh Amiri-KordestaniCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0002-0056-5437
Center for Drug Evaluation and Research · USCenter for Devices and Radiological Health · USUnited States Food and Drug Administration · US

Funding

FDA HHSIntramural FDA HHS FD999999
6 · The paper itself

Abstract

On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx for treatment of adult patients with folate receptor-α (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic therapies. The VENTANA FOLR1 (FOLR-2.1) RxDx Assay was approved as a companion diagnostic device to select patients for this indication. Approval was based on Study 0417 (SORAYA, NCT04296890), a single-arm, multicenter trial. In 104 patients with measurable disease who received mirvetuximab soravtansine-gynx, the overall response rate was 31.7% [95% confidence interval (CI), 22.9-41.6] with a median duration of response of 6.9 months (95% CI, 5.6-9.7). Ocular toxicity was included as a Boxed Warning in the U.S. Prescribing Information (USPI) to alert providers of the risks of developing severe ocular toxicity including vision impairment and corneal disorders. Pneumonitis and peripheral neuropathy were additional important safety risks included as Warnings and Precautions in the USPI. This is the first approval of a targeted therapy for FRα-positive, platinum-resistant ovarian cancer and the first antibody-drug conjugate approved for ovarian cancer. This article summarizes the favorable benefit-risk assessment leading to FDA's approval of mirvetuximab soravtansine-gynx.

Indexed as

ImmunoconjugatesOvarian NeoplasmsAdultAntibodies, Monoclonal, HumanizedCarcinoma, Ovarian EpithelialDrug Resistance, NeoplasmFemaleFolate Receptor 1HumansMaytansineToxic Optic NeuropathyAntibodies, Monoclonal, HumanizedFolate Receptor 1FOLR1 protein, humanImmunoconjugatesMaytansinemirvetuximab soravtansine

Identifiers

PMID37212825
PMCPMC10592645
OpenAlexW4377220075

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.