Evidence map›Paper›PMID 33288660›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2021

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer.

Sonia Singh, Adnan A Jaigirdar, Flora Mulkey, Joyce Cheng, Salaheldin S Hamed, Yangbing Li, Jiang Liu, Hong Zhao, Anwar Goheer, Whitney S Helms and 11 more

Registry-linked trialOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02454972 (A Multicenter Phase II Clinical Trial of Lurbinectedin), which is not on this map. Cited by 71 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 5% 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.

NCT02454972 phase2completednot on this map

A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

TypeinterventionalSponsorPharmaMarRan2015 to 2020Enrolled345ConditionsAdvanced Solid TumorsArmslurbinectedin (PM01183)
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 2 syntheses or guidelines pooled it, 91 citations in OpenAlex.

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11 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

21 authors at 2 institutions in 1 country.

Sonia SinghCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. sonia.singh@fda.hhs.gov.
Adnan A JaigirdarCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Flora MulkeyCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Joyce ChengCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Salaheldin S HamedCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Yangbing LiCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jiang LiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Hong ZhaoCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Anwar GoheerCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Whitney S HelmsCenter 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.
Rajiv AgarwalCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Rajan PraganiCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Kwadwo KorsahCenter 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.
John LeightonCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Atiqur RahmanCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Julia A BeaverCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Richard PazdurOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Marc R TheoretOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Harpreet SinghCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Center for Drug Evaluation and Research · USUnited States Food and Drug Administration · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Approval was granted on the basis of the clinically meaningful effects on overall response rate (ORR) and duration of response (DOR), and the safety profile observed in a multicenter, open-label, multicohort clinical trial (PM1183-B-005-14, NCT02454972), referred to as Study B-005, in patients with advanced solid tumors. The trial included a cohort of 105 patients with metastatic SCLC who had disease progression on or after platinum-based chemotherapy. The confirmed ORR determined by investigator assessment using RECIST 1.1 in the approved SCLC patient population was 35% [95% confidence interval (CI): 26-45], with a median DOR of 5.3 (95% CI: 4.1-6.4) months. The drug label includes warnings and precautions for myelosuppression, hepatotoxicity, and embryo-fetal toxicity. This is the first drug approved by the FDA in over 20 years in the second line for patients with metastatic SCLC. Importantly, this approval includes an indication for patients who have platinum-resistant disease, representing an area of particular unmet need.

Indexed as

Drug ApprovalAgedAged, 80 and overAnimalsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarbolinesCombined Modality TherapyDisease ManagementDrug Evaluation, PreclinicalFemaleHeterocyclic Compounds, 4 or More RingsHumansLung NeoplasmsMaleMiddle AgedAntineoplastic AgentsCarbolinesHeterocyclic Compounds, 4 or More RingsPM 01183

Identifiers

PMID33288660
PMCPMC9532454
OpenAlexW3111498065

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.