Medarex Announces FDA Fast Track Designations for Ipilimumab for the Treatment of Metastatic Melanoma; Fast Track Designations for First-Line Use in Combination With Chemotherapy and Second-Line Use as Monotherapy
Thursday December 7, 6:00 am ET
PRINCETON, N.J., Dec. 7 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced that the U.S. 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 (second-line) 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.
About ipilimumab
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 tumors. 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 (enrollment 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 tumor types, as well as in combination studies with chemotherapy, immunotherapy and vaccines. Further information regarding Medarex's and Bristol-Myers Squibb's ipilimumab program can be found in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).
Not a big deal. As I almost always have some difficulty with what Fast track stands for, here is what FDA has to say about the subject.
Erik
Fast Track is a formal mechanism to interact with the FDA using approaches that are available to all applicants for marketing claims. The Fast Track mechanism is described in the Food and Drug Administration Modernization Act of 1997 (FDAMA). The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints (see Accelerated Approval below). The Fast Track designation is intended for the combination of a product and a claim that addresses an unmet medical need, but is independent of Priority Review and Accelerated Approval. An applicant may use any or all of the components of Fast Track without the formal designation. Fast Track designation does not necessarily lead to a Priority Review or Accelerated Approval. An FDA Guidance on Fast Track Designation provides more detail with a citation of the relevant portion of the statue as an Appendix.
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