News & Publications

• Structure-based classification predicts drug response in EGFR-mutant NSCLC—Nature
  "One of the most important journal articles written in this field-- Bravo to Jacqulyne Ponville Robichaux, PhD, John Heymach,MD, PhD, and members of the John V. Heymach Laboratory at The University of Texas MD Anderson Cancer Center."—Marcia K. Horn, JD
• FDA Approves Mobocertinib for NSCLC with EGFR Exon 20 Insertion Mutations—Oncology Nursing News
  "As a patient advocate working with EGFR Exon20 insertion+ NSCLC patients and their families every day for nearly five years, I am thrilled to witness continued progress in the fight against this devastating disease and am grateful for the patients, families, healthcare professionals and scientists across the globe who contributed to the approval of this promising targeted therapy." —Marcia Horn, executive director, Exon 20 Group at ICAN, International Cancer Advocacy Network.
• Takeda's EXKIVITY™ (mobocertinib) Approved by U.S. FDA as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC —Business Wire
  − Approval based on Phase 1/2 trial results, which demonstrated clinically meaningful responses with a median duration of response (DoR) of approximately 1.5 years
  − Next-generation sequencing (NGS) companion diagnostic test approved simultaneously to support identification of patients with EGFR Exon20 insertion mutations
• Mobocertinib for Patients with EGFR Exon 20 Insertion-Positive Metastatic NSCLC with Disease Progression on Prior EGFR TKI Therapy
  Marcia K. Horn, JD, Executive Director, the Exon 20 Group and CEO, ICAN, International Cancer Advocacy Network—IASLC
  In reference to: OA15.01 "Mobocertinib in EGFR Exon 20 Insertion–Positive Metastatic NSCLC Patients With Disease Control on Prior EGFR TKI Therapy" presented by Dr. Alexander I. Spira | (PDF)
• Phase I studies of DZD9008, an oral selective EGFR/HER2 inhibitor for patients with advanced NSCLC and EGFR Exon20 insertion mutations
  Marcia K. Horn, JD, Executive Director, the Exon 20 Group and CEO, ICAN, International Cancer Advocacy Network—IASLC
  In reference to: OA15.02 "Phase 1 studies of DZD9008, an oral selective EGFR/HER2 inhibitor in advanced NSCLC with EGFR Exon20 insertion mutations," presented by Dr. Pasi Jänne | (PDF)