Literature DB >> 35478274

Controversy of tissue-agnostic approvals in immunotherapy and targeted therapy.

Chinmoy K Bose1.   

Abstract

In recent years, approval of some immunotherapy based on markers such as dMMR, tumour mutational burden and other few such markers is not received well as shown in post-approval data published. The context of such approvals and controversies is discussed briefly.
© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Entities:  

Keywords:  Deficient mismatch repair (dMMR); Immune checkpoint inhibitor (ICI); Microsatellite instability (MSI); NTRK; Pembrolizumab; Tumour mutational burden (TMB)

Mesh：

Substances：

Year:  2022        PMID： 35478274     DOI： 10.1007/s12032-022-01672-5

Source DB:  PubMed          Journal:  Med Oncol        ISSN： 1357-0560            Impact factor:   3.064


  7 in total

1.  The FDA approval of pembrolizumab for adult and pediatric patients with tumor mutational burden (TMB) ≥10: a decision centered on empowering patients and their physicians.

Authors:  V Subbiah; D B Solit; T A Chan; R Kurzrock
Journal:  Ann Oncol       Date:  2020-08-05       Impact factor: 32.976

2.  Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children.

Authors:  Alexander Drilon; Theodore W Laetsch; Shivaani Kummar; Steven G DuBois; Ulrik N Lassen; George D Demetri; Michael Nathenson; Robert C Doebele; Anna F Farago; Alberto S Pappo; Brian Turpin; Afshin Dowlati; Marcia S Brose; Leo Mascarenhas; Noah Federman; Jordan Berlin; Wafik S El-Deiry; Christina Baik; John Deeken; Valentina Boni; Ramamoorthy Nagasubramanian; Matthew Taylor; Erin R Rudzinski; Funda Meric-Bernstam; Davendra P S Sohal; Patrick C Ma; Luis E Raez; Jaclyn F Hechtman; Ryma Benayed; Marc Ladanyi; Brian B Tuch; Kevin Ebata; Scott Cruickshank; Nora C Ku; Michael C Cox; Douglas S Hawkins; David S Hong; David M Hyman
Journal:  N Engl J Med       Date:  2018-02-22       Impact factor: 91.245

3.  Microsatellite-Stable Tumors with High Mutational Burden Benefit from Immunotherapy.

Authors:  Aaron M Goodman; Ethan S Sokol; Garrett M Frampton; Scott M Lippman; Razelle Kurzrock
Journal:  Cancer Immunol Res       Date:  2019-08-12       Impact factor: 11.151

Review 4.  From Tissue-Agnostic to N-of-One Therapies: (R)Evolution of the Precision Paradigm.

Authors:  Jacob J Adashek; Vivek Subbiah; Razelle Kurzrock
Journal:  Trends Cancer       Date:  2020-09-29

Review 5.  Loose Regulatory Standards Portend a New Era of Imprecision Oncology.

Authors:  Ali Raza Khaki
Journal:  Cancer Invest       Date:  2021-01-07       Impact factor: 2.176

6.  FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors.

Authors:  Leigh Marcus; Lola A Fashoyin-Aje; Martha Donoghue; Mengdie Yuan; Lisa Rodriguez; Pamela S Gallagher; Reena Philip; Soma Ghosh; Marc R Theoret; Julia A Beaver; Richard Pazdur; Steven J Lemery
Journal:  Clin Cancer Res       Date:  2021-06-03       Impact factor: 13.801
  7 in total

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