L-MTP-PETreatment for Osteosarcoma
IDM Pharma Announces Acceptance for Review of the NDA for Junovan (Mifamurtide)
IRVINE, Calif., December 26, 2006 - IDM Pharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review IDM's New Drug Application (NDA) for Junovan (mifamurtide for injection). Junovan is intended for use in the treatment of patients with newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy.
FDA has agreed the file is sufficiently complete to allow substantive review, on a standard review basis, contingent upon IDM's commitment to provide pharmacokinetic data for the to-be-marketed Junovan product within approximately three months. The pharmacokinetic data in the submission were collected following administration of the product previously manufactured by Ciba-Geigy. The additional data that IDM has committed to obtain will provide information on the pharmacokinetic behavior of the IDM-manufactured product when administered in the clinical setting.
The European Marketing Authorization Application (MAA) for the drug (known as Mepact in Europe) is under review by the European Medicines Agency (EMEA) with the official review start date of November 22, 2006, following validation of the application as electronic common technical document (eCTD).
The Junovan marketing applications include efficacy and safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received Junovan, and from 115 patients with metastatic or unresectable osteosarcoma, 39 of whom received Junovan in the controlled Phase III trial conducted by the Pediatric Oncology Group (POG) and the Children's Oncology Group (COG), sponsored by the Division of Cancer Treatment and Diagnosis of the National Cancer Institute (NCI). The biological effects and safety of Junovan are further supported by data from 17 Phase I and II clinical studies performed by Ciba-Geigy in which an additional 248 patients received at least one dose of Junovan.
Jean-Loup Romet-Lemonne, M.D., President and CEO of IDM, stated that "The acceptance of the file for review marks a major milestone in the development of this novel immunotherapy approach which we believe will address significant unmet medical needs of children and young adults with osteosarcoma. We look forward to working closely with both regulatory agencies to respond to any questions resulting from the reviews as quickly as possible with the hope that Junovan will be made available to improve the outcome of these young patients for whom very few new therapeutic options have been made available over the last two decades."
About the Phase III trial
Junovan (mifamurtide - Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine MTP-PE) is selectively delivered to marcrophages via the scavenger lipoprotein receptor pathway, activating the tumoricidal activity through the cytoplasmic Nod2 receptor. When administered in combination with chemotherapy and after tumor resection, osteosarcoma patients in the phase III trial, patients receiving Junovan had a significant improvement in Disease Free Survival (DFS) (pless than0.0245) and Overall Survival (OS) (pless than0.0183). At 6 years, the probability of survival when Junovan is combined with adjuvant chemotherapy is 77% (95%CI:72-83%) compared to 66% (95%CI:59-73%) without Junovan, a clinically meaningful finding in a pediatric population where the longer the survival, the greater the chance that the patient is cured of cancer. Additional survival data from the COG (median follow up of 7.7 years) supports the survival benefit of Junovan in the treatment of non-metastatic osteosarcoma. The most common adverse events include chills, fever, nausea, vomiting, myalgia, headache, tachycardia (fast heart rate), hypo- and hypertension, fatigue and shortness-of-breath, generally mild to moderate in nature and consistent with the activation of monocytes and macrophages by Junovan and the flu-like symptoms that follow cytokine release.
About 3% of all childhood cancers are osteosarcoma. Because osteosarcoma usually develops from osteoblasts, it most commonly develops in teenagers who are experiencing their adolescent growth spurt. Osteosarcoma is an orphan disease and there are approximately 1000 new cases in the US each year. A similar incidence of the disease exists in Europe. According to the Children's Oncology Group (http://www.curesearch.org/our_research/index_sub.aspx?id=1761), the survival of children with osteosarcoma has remained at 60-65% since the mid-1980s. The standard treatment for osteosarcoma is tumor resection with combination chemotherapy before and after surgery.
Source: IDM Pharma
Posted: December 2006
- IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma - August 27, 2007
- IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide (L-MTP-PE) for the Treatment of Patients with Osteosarcoma - July 23, 2007
- FDA Advisory Committee Reviews Data on IDM Pharma's Junovan (mifamurtide) for Treatment of Osteosarcoma - May 9, 2007
- IDM Pharma Inc. Announces Oncologic Drugs Advisory Committee Meeting for Junovan (Mifamurtide) Will Take Place on May 9, 2007 - April 3, 2007
- IDM Pharma Submits New Drug Application to the FDA for Junovan (mifamurtide) in the Treatment of Osteosarcoma - October 26, 2006