Evidence map›Paper›PMID 28751443›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2017

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious

Sanjeeve Balasubramaniam, Julia A Beaver, Sara Horton, Laura L Fernandes, Shenghui Tang, Hisani N Horne, Jinzhong Liu, Chao Liu, Sarah J Schrieber, Jingyu Yu and 16 more

Abstract read
PubMed Publisher
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Aging and cancer: current understandings and future perspectives.Signal transduction and targeted therapy · 2026
    Review
  6. Review
  7. Dynamic Assemblies in Genome Maintenance.Advances in experimental medicine and biology · 2026
    Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. A new wave of innovations within the DNA damage response.Signal transduction and targeted therapy · 2023
    Review
  19. Review
  20. Article

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

4 · The record

Corrections and comments

  • Commented on by
    The2017
5 · Who and what money

Authors and funding

26 authors.

Sanjeeve BalasubramaniamCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. sanjeeve.balasubramaniam@fda.hhs.gov.
Julia A BeaverCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Sara HortonCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Laura L FernandesCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Shenghui TangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Hisani N HorneCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jinzhong LiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Chao LiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Sarah J SchrieberCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jingyu YuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Pengfei SongCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
William PierceCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kim J RobertsonCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Todd R PalmbyCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Haw-Jyh ChiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Eunice Y LeeCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Reena PhilipCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Robert SchuckCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Rosane CharlabCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Anamitro BanerjeeCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Xiao Hong ChenCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Xing WangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kirsten B GoldbergCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Rajeshwari SridharaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Geoffrey KimCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Richard PazdurCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

On December 19, 2016, the FDA granted accelerated approval to rucaparib (RUBRACA; Clovis Oncology, Inc.) for the treatment of patients with deleterious

Indexed as

Drug ApprovalGenes, BRCA1Genes, BRCA2MutationClinical Trials as TopicFemaleHumansIndolesMulticenter Studies as TopicOvarian NeoplasmsPoly(ADP-ribose) Polymerase InhibitorsRetrospective StudiesTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationIndolesPoly(ADP-ribose) Polymerase Inhibitorsrucaparib

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.