(Q42281334)

English

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.

scientific article published on 4 October 2017

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scholarly article

1 reference

Europe PubMed Central

19 October 2017

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. (English)

1 reference

Europe PubMed Central

19 October 2017

quality of life

1 reference

based on heuristic

inferred from title

object named as

Courtney Davis

1

0 references

author name string

Huseyin Naci

2

1 reference

Europe PubMed Central

19 October 2017

Evrim Gurpinar

3

1 reference

Europe PubMed Central

19 October 2017

Elita Poplavska

4

1 reference

Europe PubMed Central

19 October 2017

Ashlyn Pinto

5

1 reference

Europe PubMed Central

19 October 2017

Ajay Aggarwal

6

1 reference

Europe PubMed Central

19 October 2017

language of work or name

0 references

publication date

4 October 2017

1 reference

Europe PubMed Central

19 October 2017

1 reference

Europe PubMed Central

19 October 2017

359

1 reference

Europe PubMed Central

19 October 2017

j4530

1 reference

Europe PubMed Central

19 October 2017

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review

1 reference

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26 October 2017

Do patient access schemes for high-cost cancer drugs deliver value to society?-lessons from the NHS Cancer Drugs Fund

1 reference

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26 October 2017

Relevance of randomised controlled trials in oncology.

1 reference

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26 October 2017

Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

1 reference

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26 October 2017

Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014

1 reference

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26 October 2017

Cancer Drugs Provide Positive Value In Nine Countries, But The United States Lags In Health Gains Per Dollar Spent

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Phase III, randomized study of ofatumumab versus physicians' choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia.

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26 October 2017

Early market access of cancer drugs in the EU.

1 reference

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Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial

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The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses

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26 October 2017

Use of the conditional marketing authorization pathway for oncology medicines in Europe.

1 reference

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A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).

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26 October 2017

Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer

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26 October 2017

Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses

1 reference

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26 October 2017

Outcomes and endpoints in cancer trials: bridging the divide

1 reference

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26 October 2017

nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial.

1 reference

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26 October 2017

Drugs, cancer and end-of-life care: a case study of pharmaceuticalization?

1 reference

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26 October 2017

Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Validation of surrogate endpoints in advanced solid tumors: systematic review of statistical methods, results, and implications for policy makers.

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https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Safety and efficacy of vemurafenib in BRAF(V600E) and BRAF(V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study

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26 October 2017

Pazopanib versus sunitinib in metastatic renal-cell carcinoma

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Crizotinib versus chemotherapy in advanced ALK-positive lung cancer.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Cancer drugs in the United States: Justum Pretium--the just price

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Trastuzumab emtansine for HER2-positive advanced breast cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Increased survival with enzalutamide in prostate cancer after chemotherapy

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Rare cancer trial design: lessons from FDA approvals

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Adjuvant trastuzumab in HER2-positive breast cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Ipilimumab plus dacarbazine for previously untreated metastatic melanoma

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: when differences have an impact on clinical practice

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

American Society of Clinical Oncology Statement: Toward Individualized Care for Patients With Advanced Cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Improved Survival with Ipilimumab in Patients with Metastatic Melanoma

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Progression-free survival is simply a measure of a drug's effect while administered and is not a surrogate for overall survival.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

How much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Evolution of the randomized controlled trial in oncology over three decades

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Endpoints for assessing drug activity in clinical trials

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Osteosarcoma: the addition of muramyl tripeptide to chemotherapy improves overall survival--a report from the Children's Oncology Group

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Efficacy, safety, and cost of new anticancer drugs

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https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

26 October 2017

How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers' views

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29 May 2018

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29 May 2018

Overestimating the Benefit of Cancer Drugs-Reply.

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17 August 2018

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17 August 2018

The Association of Cancer Physicians responds to "Cancer drugs, survival, and ethics".

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17 August 2018

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17 August 2018

Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†.

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17 August 2018

Unintended consequences of expensive cancer therapeutics—the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture

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17 August 2018

Impact of low-grade adverse events on health-related quality of life in adult patients receiving imatinib or nilotinib for newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

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17 August 2018

Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer

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17 August 2018

PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

17 August 2018

Quality of life (QoL) analyses from OPTIMAL (CTONG-0802), a phase III, randomised, open-label study of first-line erlotinib versus chemotherapy in patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC).

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5627352

17 August 2018

Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 Study

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17 August 2018

Progression-free survival: meaningful or simply measurable?

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17 August 2018

Poor correlation between progression-free and overall survival in modern clinical trials: are composite endpoints the answer?

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17 August 2018

RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer

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17 August 2018

Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study.

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17 August 2018

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17 August 2018

Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study.

1 reference

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17 August 2018

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1 reference

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17 August 2018

Does palliative chemotherapy palliate? Evaluation of expectations, outcomes, and costs in women receiving chemotherapy for advanced ovarian cancer.

1 reference

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17 August 2018

Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival

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1 December 2018

Reality check for pemetrexed and maintenance therapy in advanced non-small-cell lung cancer

1 reference

https://pubmed.ncbi.nlm.nih.gov/28978555

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Overestimating the Benefit of Cancer Drugs

1 reference

https://pubmed.ncbi.nlm.nih.gov/28978555

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort

1 reference

https://pubmed.ncbi.nlm.nih.gov/28978555

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints

1 reference

https://pubmed.ncbi.nlm.nih.gov/28978555

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Approvals in 2016: questioning the clinical benefit of anticancer therapies

1 reference

https://pubmed.ncbi.nlm.nih.gov/28978555

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Raising the bar for market authorisation of new drugs

1 reference

https://pubmed.ncbi.nlm.nih.gov/28978555

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Why do cancer drugs get such an easy ride?

1 reference

https://pubmed.ncbi.nlm.nih.gov/28978555

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Why do our patients get chemotherapy until the end of life?

1 reference

https://pubmed.ncbi.nlm.nih.gov/28978555

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Identifiers

10.1136/BMJ.J4530

1 reference

Europe PubMed Central

19 October 2017

1 reference

Europe PubMed Central

19 October 2017

1 reference

Europe PubMed Central

19 October 2017

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