FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Leigh MarcusRichard Pazdur

Abstract

The FDA approved pembrolizumab on May 23, 2017, for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and for the treatment of unresectable or metastatic MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The FDA granted the approval based on an understanding of the biology of MSI-H/dMMR across different tumors along with the clinically important effects on overall response rate (ORR) observed in patients who were enrolled in 1 of 5 single-arm clinical trials. The ORR was 39.6% among 149 patients with 15 different tumor types (95% confidence interval, 31.7-47.9), with a 7% complete response rate. The duration of response ranged from 1.6+ months to 22.7+ months, with 78% of responses lasting ≥6 months. Overall, the adverse event profile of pembrolizumab was similar to the adverse event profile observed across prior trials that supported the approval of pembrolizumab in other indications. This approval of pembrolizumab is the first tim...Continue Reading

References

Jul 9, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Stephen YipDavid N Louis
Aug 21, 2014·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Sabine VenderboschMiriam Koopman
Jun 2, 2015·The New England Journal of Medicine·Dung T LeLuis A Diaz
Sep 12, 2015·Science·Eliezer M Van AllenLevi A Garraway
Mar 24, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eric BouffetUri Tabori
Mar 30, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Zsofia K StadlerLeonard B Saltz
Nov 1, 2016·Nature Medicine·Ronald J HauseStephen J Salipante
Nov 20, 2016·Journal of Neurosurgery. Pediatrics·Xiao ZhuMandeep S Tamber
Jun 1, 2017·American Society of Clinical Oncology Educational Book·Keith T FlahertySteven Lemery
Oct 12, 2017·The New England Journal of Medicine·Steven LemeryRichard Pazdur

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Citations

Jul 28, 2019·Annals of Oncology : Official Journal of the European Society for Medical Oncology·D RodaA Cervantes
Dec 4, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Landon C Brown, Andrew J Armstrong
Dec 14, 2019·Current Opinion in Obstetrics & Gynecology·Maria M Rubinstein, Vicky Makker
Jan 7, 2020·Expert Review of Molecular Diagnostics·Aline Bobato Lara GongoraDenis Leonardo Jardim
Nov 2, 2019·Journal of Pathology and Translational Medicine·Yoonjin KwakHye Seung Lee
Jan 23, 2020·Cancers·Kenji Nakano, Shunji Takahashi
Feb 8, 2020·CA: a Cancer Journal for Clinicians·Jay J H ParkEdward J Mills
Nov 22, 2019·The Oncologist·Jacob J AdashekRazelle Kurzrock
Jan 31, 2020·International Journal of Cancer. Journal International Du Cancer·Eleonore De GuillebonEric Tartour
Mar 14, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Vicky MakkerAntonio Casado Herraez
Mar 25, 2020·American Society of Clinical Oncology Educational Book·Mohamed E SalemJeanne Tie
Mar 14, 2020·Current Opinion in Oncology·Catherine H Marshall, Emmanuel S Antonarakis
Apr 22, 2020·American Society of Clinical Oncology Educational Book·Galina G LagosNaiyer A Rizvi
Apr 29, 2020·American Society of Clinical Oncology Educational Book·Daniel Vargas P de AlmeidaKaren A Autio
Jun 25, 2019·ESMO Open·Marleen KokJohn Haanen
May 13, 2020·British Journal of Clinical Pharmacology·Geoffrey Alan WatsonAnna Spreafico
May 7, 2020·British Journal of Clinical Pharmacology·Hui Yi ChewFiona Simpson
Jun 20, 2020·Expert Review of Molecular Diagnostics·Iosune BaraibarElena Élez
Jun 25, 2020·ESMO Open·Gilbert SpizzoAndreas Seeber
Jul 10, 2020·Cancer Medicine·Michelle SaulJeff Swensen
Jun 15, 2020·Clinical Pharmacology and Therapeutics·Nathan D SeligsonChristine M Walko
Jul 8, 2020·Journal of the National Comprehensive Cancer Network : JNCCN·Rahel DemisseMay Cho
Aug 1, 2020·Oncotarget·Karen YunSandip Pravin Patel
Aug 14, 2020·American Journal of Clinical Pathology·Matthew George GayhartSteven Christopher Smith
Jun 6, 2020·Zeitschrift für Gastroenterologie·Sabrina WellandArndt Vogel
Sep 17, 2020·ESMO Open·Nikki Burdett, Jayesh Desai
Sep 29, 2019·Medical Sciences : Open Access Journal·Adam BarsoukAlexander Barsouk
Jan 19, 2020·Expert Opinion on Biological Therapy·Dahna CoupezJaafar Bennouna
Aug 15, 2020·Frontiers in Cell and Developmental Biology·Qingyang LeiYi Zhang
Dec 29, 2019·Scientific Reports·H TaghizadehG W Prager
Nov 16, 2019·Proceedings of the National Academy of Sciences of the United States of America·Shaogeng Tang, Peter S Kim
Jun 17, 2020·Therapeutic Advances in Gastroenterology·Gol Golshani, Yue Zhang
Sep 12, 2020·Journal of Clinical Medicine·Catalin ConstantinescuCiprian Tomuleasa
Jul 4, 2020·Clinical & Translational Immunology·Yi-Ru PanChun-Nan Yeh

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