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

Rezurock Novel Oral Therapy FDA Approved for Chronic Graft-Versus-Host Disease

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

On July 16, 2021, the FDA accelerated the approval of belumosudil (Rezurock; Kadmon Pharmaceuticals), an oral kinase inhibitor, for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) who have received ≥2 lines of systemic therapy. Belumosudil was granted a breakthrough therapy designation for this indication.

“Rezurock represents a new treatment paradigm for thousands of chronic GVHD patients, including those with difficult-to-treat manifestations like fibrosis,” said Corey Cutler, MD, MPH, FRCPC, Associate Professor of Medicine, Harvard Medical School, and Medical Director, Adult Stem Cell Transplantation Program, Dana-Farber Cancer Institute, Boston. “Rezurock has shown robust and durable responses across the spectrum of chronic GVHD, and is safe and well-tolerated.”

Belumosudil was approved based on the KD025-213 study, a randomized, open-label, multicenter dose-ranging clinical trial of 65 patients with chronic GVHD who received belumosudil 200 mg once daily. The main efficacy measure was overall response rate (ORR) through cycle 7 of day 1.

The ORR was 75% (95% confidence interval, 63%-85%), which included 6% complete responses and 69% partial responses. The median time to first response was 1.8 months. The median duration of response was 1.9 months. Among the patients who achieved a response, no death or new systemic therapy initiation occurred in 62% of the patients for at least 12 months since the response.

The most common (≥20%) adverse events were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension.

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.