Stay Up
to Date
Stay Up
to Date
Breaking News,
Updates, & More
Breaking News,
Updates, & More
Click Here to
Subscribe
Click Here to
Subscribe

Inrebic Receives FDA Approval for Adults with Myelofibrosis

Web Exclusives - FDA Updates

On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene/Impact Biomedicines), an oral kinase inhibitor, for adults with intermediate-2 or high-risk primary or secondary—post–polycythemia vera (PV) or post–essential thrombocythemia (ET)—myelofibrosis, a rare bone marrow disorder. The FDA granted fedratinib priority review and an orphan drug designation.

“Myelofibrosis can cause patients to suffer in many ways, including experiencing debilitating symptoms,” said Ruben Mesa, MD, FACP, Director, Mays Cancer Center, San Antonio M.D. Anderson Cancer Center. “There has not been a new treatment approved for this disease in nearly a decade.”

The FDA approved fedratinib based on the JAKARTA study, a phase 3, double-blind, randomized, placebo-­controlled clinical trial of 289 patients with intermediate-2 or high-risk myelofibrosis, post-PV myelofibrosis, or post-ET myelofibrosis with splenomegaly. Patients were randomized to 400 mg or 500 mg of fedratinib or to placebo once daily for at least 6 cycles.

The primary outcome was the proportion of patients achieving ≥35% reduction from baseline in spleen volume after 6 cycles of treatment. Of the 96 patients who received 400 mg of fedratinib, 35 (37%) achieved a ≥35% reduction in spleen volume versus 1 of 96 patients who received placebo (P <.0001). The median duration of spleen response was 18.2 months with 400 mg of fedratinib. In addition, 40% of patients who received the 400-mg dose had a ≥50% reduction in myelofibrosis-related symptoms versus only 9% of patients receiving placebo.

The most common (≥20%) side effects were diarrhea, nausea, anemia, and vomiting. Fedratinib was approved with a boxed warning about the risk for serious and fatal encephalopathy, including Wernicke’s encephalopathy.

Related Items
Lynparza First Targeted Therapy Approved for Metastatic Prostate Cancer with HRR Mutation
Web Exclusives published on May 26, 2020 in FDA Updates, Prostate Cancer
Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
Web Exclusives published on May 26, 2020 in FDA Updates, Lung Cancer
FDA News
TOP - May 2020, Vol 13, No 3 published on May 21, 2020 in FDA Updates
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
Web Exclusives published on May 18, 2020 in FDA Updates, Lung Cancer
Tabrecta First FDA-Approved Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping
Web Exclusives published on May 11, 2020 in FDA Updates
Retevmo First Therapy Approved for 3 Types of Cancers with RET Mutations
Web Exclusives published on May 11, 2020 in FDA Updates
FDA Approves Darzalex Faspro as Subcutaneous Formulation for All Patients with Multiple Myeloma
Web Exclusives published on May 5, 2020 in FDA Updates
Zejula First PARP Inhibitor Approved as First-Line Maintenance Treatment for All Patients with Ovarian Cancer
Web Exclusives published on May 4, 2020 in FDA Updates
FDA Approves New 400 mg Every-6-Weeks Dosing Regimen of Keytruda for All Indications
Web Exclusives published on April 30, 2020 in FDA Updates
Jelmyto First FDA-Approved Therapy for Low-Grade Upper-Tract Urothelial Cancer
Web Exclusives published on April 21, 2020 in FDA Updates, Urothelial Cancer
Last modified: April 27, 2020