Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

NEW DRUGS

Exkivity Novel Oral Targeted Therapy Approved for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

JHOP - October 2021 Vol 11, No 5 - FDA Updates
Download PDF

On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda), an oral kinase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease progressed during or after platinum-based chemotherapy. Mobocertinib received breakthrough therapy and orphan drug designations for this indication.

On the same day, the FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic test for the identification of candidates for mobocertinib therapy.

EGFR Exon 20 insertion-positive NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs,” Pasi A. Jänne, MD, PhD, of Dana-Farber Cancer Institute, said in a statement. “The approval of Exkivity (mobocertinib) marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses.”

The FDA approved mobocertinib based on Study 101, an international, nonrandomized, open-label, multicohort clinical trial of 114 patients with locally advanced or metastatic NSCLC and EGFR exon 20 insertion mutations, whose disease progressed during or after platinum-based chemotherapy. Patients received oral mobocertinib 160 mg daily, until disease progression or intolerable adverse events.

The main efficacy measures were overall response rate (ORR) and response duration. The ORR was 28% (95% confidence interval [CI], 20%-37%), with a median response duration of 17.5 months (95% CI, 7.4-20.3).

The most common (>20%) adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. Mobocertinib was approved with boxed warnings about risk for corrected QT prolongation and Torsades de Pointes, interstitial lung disease or pneumonitis, cardiac adverse reactions, and diarrhea.

Continued approval of this indication may be contingent on confirmatory data from a clinical trial.

Related Items
Cytalux, a Novel Imaging Agent, FDA Approved for Diagnosing Inoperable Ovarian Cancer Lesions
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
FDA Approved Fyarro for Malignant Perivascular Epithelioid-Cell Tumor
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
Oral Scemblix FDA Approved for Patients with Ph-Positive Chronic Myeloid Leukemia
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
Darzalex Faspro, Kyprolis, and Dexamethasone a New Combination FDA Approved for Multiple Myeloma
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
Keytruda Now FDA Approved for Adjuvant Treatment of Renal-Cell Carcinoma
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
Tecentriq First Immunotherapy FDA Approved for Adjuvant Treatment of Early-Stage Non–Small-Cell Lung Cancer
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
Keytruda plus Chemotherapy FDA Approved for First-Line Treatment of Cervical Cancer
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
Verzenio with Endocrine Therapy FDA Approved for Adjuvant Treatment of Early Breast Cancer
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
Tecartus FDA Approved for Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
JHOP - December 2021 Vol 11, No 6 published on December 17, 2021 in FDA Updates
Tivdak First Antibody–Drug Conjugate FDA Approved for Recurrent or Metastatic Cervical Cancer
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.