Assessment of benefits and risks in development of targeted therapies for cancer--The view of regulatory authorities (Q38284222)

1 September 2017

1 reference

title

Assessment of benefits and risks in development of targeted therapies for cancer--The view of regulatory authorities (English)

1 reference

1 September 2017

Francesco Pignatti

1 reference

1 September 2017

Bertil Jonsson

series ordinal

1 reference

1 September 2017

Gideon Blumenthal

series ordinal

1 reference

1 September 2017

Robert Justice

series ordinal

1 reference

1 September 2017

16 October 2014

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1 September 2017

1 reference

1 September 2017

1 reference

1 September 2017

1 reference

1 September 2017

1034-1041

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Balancing benefit and risk of medicines: a systematic review and classification of available methodologies

1 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Strategies to overcome clinical, regulatory, and financial challenges in the implementation of personalized medicine

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

The BATTLE trial: personalizing therapy for lung cancer

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Adaptive licensing: taking the next step in the evolution of drug approval

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Role of randomized phase III trials in an era of effective targeted therapies

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Accelerated Approval of Oncology Products: The Food and Drug Administration Experience

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Are Gastroenterologists Less Tolerant of Treatment Risks than Patients? Benefit-Risk Preferences in Crohn's Disease Management

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

FDA drug approval summary: bevacizumab (Avastin) as treatment of recurrent glioblastoma multiforme

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

NICE at 10 years: new challenges ahead

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

FDA drug approval summary: panitumumab (Vectibix).

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Why do patients choose chemotherapy near the end of life? A review of the perspective of those facing death from cancer.

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Patients preferences in chemotherapy for advanced non-small-cell lung cancer

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Cancer patients, doctors and nurses vary in their willingness to undertake cancer chemotherapy

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer

6 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma

31 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial.

31 August 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=5528738

End points and United States Food and Drug Administration approval of oncology drugs

31 August 2018

1 reference

Crossref

https://api.crossref.org/works/10.1016%2FJ.MOLONC.2014.10.003

Implementing personalized cancer care

21 January 2018

1 reference

Crossref

https://api.crossref.org/works/10.1016%2FJ.MOLONC.2014.10.003

Application of the BRAT Framework to Case Studies: Observations and Insights

21 January 2018

1 reference

Crossref

https://api.crossref.org/works/10.1016%2FJ.MOLONC.2014.10.003

Reevaluating the accelerated approval process for oncology drugs

21 January 2018

1 reference

12 December 2020

Pathological complete response and accelerated drug approval in early breast cancer

1 reference

12 December 2020

Safe drugs and the cost of good intentions

1 reference

12 December 2020

The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation

1 reference

12 December 2020

10.1016/J.MOLONC.2014.10.003

Identifiers

DOI

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1 September 2017

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1 September 2017

PubMed publication ID

25481691

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