Medarex, Inc. announced that the US Food and Drug Administration (FDA) has granted fast track designation for ipilimumab (also known as MDX-010) used in combination with chemotherapy (dacarbazine) in previously untreated (first-line) metastatic melanoma patients.
The FDA also has granted Fast Track designation for ipilimumab used as a monotherapy in previously treated metastatic melanoma patients.
Under the FDA Modernization Act of 1997, designation as a fast track product for a new drug or biological product means that the FDA has determined that the drug or biologic is intended for the treatment of a serious or life- threatening condition and demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate the clinical development and expedite the review of a Biologics License Application for the product.
"We are pleased with the fast track designations as we continue to work with our partner Bristol-Myers Squibb to advance the development of ipilimumab, and we believe that ipilimumab has the potential to play an important role in the fight against cancer," said Irwin Lerner, chairman of the board of directors and interim president and CEO of Medarex.
Ipilimumab is an investigational fully human antibody against human CTLA- 4, a molecule on T cells that is believed to be responsible for suppressing the immune response. Medarex and Bristol-Myers Squibb are investigating the potential of ipilimumab to enable the immune systems of cancer patients to help suppress or eradicate cancer tumours. Ipilimumab is currently under investigation in several registrational clinical trials under Special Protocol Assessment agreements with the FDA for the treatment of metastatic melanoma as a first-line treatment in combination with dacarbazine, as a second-line monotherapy (enrolment expected to be completed this year) and as a second- line treatment in combination with MDX-1379 (a melanoma peptide vaccine).
The combination with MDX-1379 was previously granted fast track designation. Ipilimumab is also being evaluated in multiple phase II clinical trials to investigate the product's potential activity in other tumour types, as well as in combination studies with chemotherapy, immunotherapy and vaccines.
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners.
Thirty-four of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with six of the most advanced product candidates currently in phase III clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs.