Evidence map›Paper›PMID 33017510›Full record

Trial reportThe oncologist2021

FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer.

Shaily Arora, Sanjeeve Balasubramaniam, Hui Zhang, Tara Berman, Preeti Narayan, Daniel Suzman, Erik Bloomquist, Shenghui Tang, Yutao Gong, Rajeshwari Sridhara and 10 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 108 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 3 pooled it
18.5field-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.

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

108 citing papers in PubMed, 3 syntheses or guidelines pooled it, 179 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Trial
  5. Sotorasib inThe New England journal of medicine · 2023
    Trial
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  18. Histamine HInflammation research : official journal of the European Histamine Research Society ... [et al.] · 2025
    Review
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  20. Article

48 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

20 authors at 3 institutions in 1 country.

Shaily AroraCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Sanjeeve BalasubramaniamCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Hui ZhangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Tara BermanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Preeti NarayanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Daniel SuzmanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Erik BloomquistCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Shenghui TangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Yutao GongCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Rajeshwari SridharaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Francisca Reyes TurcuCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Deb ChatterjeeCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Banu Saritas-YildirimCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Soma GhoshCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Reena PhilipCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Anand PathakCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Jennifer J GaoCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Laleh Amiri-KordestaniCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Richard PazdurOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Julia A BeaverOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Center for Drug Evaluation and Research · USUnited States Food and Drug Administration · USCenter for Devices and Radiological Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

On December 19, 2018, the U.S. Food and Drug Administration (FDA) granted approval to olaparib monotherapy for first-line maintenance treatment of BRCA-mutated (BRCAm) advanced ovarian cancer and, on May 8, 2020, expanded the indication of olaparib to include its use in combination with bevacizumab for first-line maintenance treatment of homologous recombination deficient (HRD)-positive advanced ovarian cancer. Both these approvals were based on randomized, double-blind, placebo-controlled trials. Approval for olaparib monotherapy was based on the SOLO-1 trial, comparing the efficacy of olaparib versus placebo in patients with BRCAm advanced ovarian, fallopian tube, or primary peritoneal cancer after surgical cytoreduction and first-line platinum-based chemotherapy. Two companion diagnostic (CDx) tests were approved with this indication: BRACAnalysis CDx, for germline BRCA1/2 alterations, and FoundationOne CDx, for BRCA1/2 alterations in tissue specimens. Approval for olaparib in combination with bevacizumab was based on the results of the PAOLA-1 trial that compared olaparib with bevacizumab versus placebo plus bevacizumab in patients with advanced high-grade epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer after first-line platinum-based chemotherapy and bevacizumab. Myriad myChoice CDx was designated as a companion diagnostic device for use of olaparib plus bevacizumab combination for ovarian cancer associated with HRD-positive status. Both trials demonstrated clinically meaningful improvements in progression-free survival and favorable benefit-risk profiles for the indicated populations. This article summarizes the FDA thought process and data supporting the approval of olaparib as monotherapy and in combination with bevacizumab for maintenance therapy in this setting. IMPLICATIONS FOR PRACTICE: These approvals represent the first poly (ADP-ribose) polymerase inhibitor, alone or in combination with bevacizumab, approved in first-line maintenance treatment of women with advanced ovarian cancer after cytoreductive surgery and chemotherapy. In patients with BRCA-mutated tumors, olaparib monotherapy demonstrated a 70% reduction in the risk of disease progression or death compared with placebo, and olaparib in combination with bevacizumab demonstrated a 67% reduction in the risk of disease progression or death compared with bevacizumab alone in homologous recombination deficient-positive tumors. These approvals represent a major advance for the treatment of women with advanced ovarian cancer who are in complete or partial response after their initial platinum-based chemotherapy.

Indexed as

Ovarian NeoplasmsPhthalazinesBevacizumabCarcinoma, Ovarian EpithelialDouble-Blind MethodFemaleHumansPiperazinesUnited StatesUnited States Food and Drug AdministrationBevacizumabolaparibPhthalazinesPiperazinesOlaparibOlaparib in combination with bevacizumabOvarian cancerPARP inhibitors

Identifiers

PMID33017510
PMCPMC7794199
OpenAlexW3090114554

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.