OBR Daily Commentary

forumImage

Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

(Takeda) Apr 27, 2021 - Takeda Pharmaceutical Company Limited today announced that that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy. Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.

Read Article arrow

H. Jack West, MD (Posted: April 28, 2021)

quotes

Though the activity of this targeted therapy isn't at the same level as that of osimertinib vs. an activating EGFR exon 19 or 21 mutation, or as that of alectinib vs. ALK-positive NSCLC, there remains a real unmet need for a targeted therapy against EGFR exon 20 mutations. We'd certainly welcome mobocertinib into the clinic for these patients.

quotes

Reply

Add Comment 1 Comment(s)

Meet the Editorial Board

Prostate Cancer
member photo
Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
member photo
Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
member photo
Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
member photo
H. Jack West, MD

Associate Clinical Professor, Medical Oncology Executi...

Gastrointestinal Cancers
member photo
Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
member photo
Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics Professo...

Editor-In-Chief
member photo
Robert A. Figlin, MD., FACP

Steven Spielberg Family Chair in Hematology Oncology P...

member photo
Stephen M. Schleicher, M.D., MBA

Community Oncology, Medical Oncologist, OneOncology...

Health Policy
member photo
Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
member photo
Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Health Policy
member photo
William McGivney, PhD

National Health Policy Expert...