FDA decisions on new oncological drugs

Between 1992 and 2019, the FDA used surrogate endpoints approximately 194 times to approve cancer drugs, with 58 regular approvals and nine accelerated approvals based on progression-free survival. [...]in lung cancer alone, several drugs have been solely approved based on response rate or degree of...

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Bibliographic Details
Published inThe lancet oncology Vol. 23; no. 5; pp. 585 - 586
Main Authors Benjamin, David J, Prasad, Vinay, Lythgoe, Mark P
Format Journal Article
LanguageEnglish
Published England Elsevier Ltd 01.05.2022
Elsevier Limited
Subjects
Biological products
Cancer therapies
Chemotherapy
Clinical trials
Drugs
Ethnicity
FDA approval
Gefitinib
Humans
Immunotherapy
Lung cancer
Medical Oncology
Medical research
Metastasis
Monoclonal antibodies
Non-small cell lung carcinoma
Oncology
Patients
Pembrolizumab
Pharmaceutical industry
Targeted cancer therapy
Tumors
United States
United States Food and Drug Administration
United States
San Francisco California
California
United States > US
China
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Summary:Between 1992 and 2019, the FDA used surrogate endpoints approximately 194 times to approve cancer drugs, with 58 regular approvals and nine accelerated approvals based on progression-free survival. [...]in lung cancer alone, several drugs have been solely approved based on response rate or degree of tumour shrinkage, including ceritinib, gefitinib, alectinib, crizotinib, brigatinib, osimertinib, lorlatinib, and dabrafenib plus trametinib. [...]the control group used in ORIENT-11 was placebo in combination with platinum-based chemotherapy. The approval of cemiplimab was based on Study 1624, which was conducted in 24 countries with the notable exception of the USA. [...]despite FDA approval of pembrolizumab for advanced NSCLC with a TPS of at least 50% on Oct 24, 2016, the comparator group in that study was chemotherapy, which was not the standard of care at the time of trial enrolment on May 29, 2017.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1470-2045
1474-5488
DOI:10.1016/S1470-2045(22)00135-8