Celgene bags Inrebic FDA approval for myelofibrosis

Inrebic FDA approval : Celgene’s subsidiary Impact Biomedicines, has bagged approval for its oral kinase inhibitor Inrebic (fedratinib) capsules from the US Food and Drug Administration (FDA) for the treatment of certain types of myelofibrosis, a rare bone marrow cancer.

Fedratinib FDA approval is for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Inrebic FDA approval is the second approval for myelofibrosis in nearly a decade for myelofibrosis by the FDA after Jakafi (ruxolitinib), which was approved in 2011.

According to the FDA, myelofibrosis is a chronic disorder in which scar tissue forms in the bone marrow. Production of the blood cells moves from the bone marrow to the spleen and liver leading to organ enlargement.

Celgene secures Inrebic FDA approval for myelofibrosis. Bobjgalindo/Wikipedia.org.

Commenting on Inrebic FDA approval, Richard Pazdur – director of the FDA Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research, said: “Prior to today, there was one FDA-approved drug to treat patients with myelofibrosis, a rare bone marrow disorder. Our approval today provides another option for patients.

“The FDA is committed to encouraging the development of treatments for patients with rare diseases and providing alternative options, as not all patients respond in the same way.”

Basis for Inrebic FDA approval – Fedratinib FDA approval

Inrebic FDA approval was based on the data of a phase 3 clinical trial – JAKARTA, featuring 289 myelofibrosis patients, who were randomly grouped to be subjected to two different doses – 400 mg or 500 mg daily by the mouth of fedratinib or placebo.

The JAKARTA clinical trial proved that 35 of 96 patients on fedratinib 400 mg daily dose had a significant therapeutic effect. This was measured by at least 35% reduction from baseline in spleen volume at the end of cycle 6, that is week 24, as measured by an MRI or CT scan with a follow-up scan four weeks later.

Inrebic was previously granted priority review designation and also orphan drug designation by the FDA.

“The approval of INREBIC is another important milestone for Celgene and underscores our commitment to people living with blood cancers,” said Jay Backstrom, M.D., M.P.H., Chief Medical Officer for Celgene. “We are excited to provide INREBIC as a new treatment option that may be used in patients with myelofibrosis, including patients previously treated with ruxolitinib.”

Jay Backstrom – Chief Medical Officer for Celgene, commenting on Inrebic FDA approval, said: “The approval of INREBIC is another important milestone for Celgene and underscores our commitment to people living with blood cancers.

“We are excited to provide INREBIC as a new treatment option that may be used in patients with myelofibrosis, including patients previously treated with ruxolitinib.”

INREBIC is an oral kinase inhibitor which acts against wild type and mutationally triggered Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). The new FDA approved myelofibrosis drug is a JAK2-selective inhibitor having higher potency for JAK2 over family members JAK1, JAK3, and TYK2. Abnormal activation of JAK2 is related to myelofibrosis, polycythemia vera, and other myeloproliferative neoplasms.