March 2011 FDA Updates

As of February 3, 2011, Hospira, Inc. announced that the FDA has approved their topotecan Injection, the first solution of the oncology drug approved in the United States. Hospira, Inc. is the world leader in generic injectable pharmaceuticals. Its topotecan injection is the generic version of Hycamtin, which sold more than $140 million in 2010. The indicated uses for topotecan are for the treatment of small-cell lung cancer sensitive disease after failure of first-line chemotherapy. The solution formulation is designed for caregiver convenience and is expected to be launched by Hospira by the end of February.

The FDA approved the Selenia Dimensions System, the first X-ray mammography device, which provides 3-dimensional images of the breast for breast cancer screening and diagnosis, on February 11, 2011. The approved device is thought to provide the best tool for early detection of breast cancer. The 3-D images produced by the system may help physicians more accurately detect and diagnose breast cancer in its early stages. When breast cancer is detected early and still localized to the breast, there is a 98% survival rate. All healthcare professionals must complete a required 8 hours of training prior to using new mammography technology, according to the Mammography Quality Standards Act.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) met in early February to discuss the value of the FDA’s accelerated approval program for cancer drugs. The accelerated approval program is in place to provide innovative and promising treatments to patients faster than the traditional route to FDA approval. There have been many accelerated drug approvals in the past, which include Gleevac, the oral drug used to treat chronic myeloid leukemia. Accelerated drug approval is based on likely, but not yet proven, clinical benefit. The committee discussed the design of the trials required for accelerated approval in addition to postmarking studies. The FDA Office of Oncology would like drug makers to have confirmatory trials underway, with set completion dates at the time of accelerated approval, if possible.

As of February 2011, the FDA granted Bayer Healthcare orphan drug designation for its drug regorafenib, an oral multi-kinase inhibitor. The designation was based on a randomized, double-blind, placebo-controlled Phase III study where regorafenib plus best supportive care was compared to placebo plus best supportive care in subjects with metastatic and/or unresectable gastrointestinal stromal tumors. These subjects experienced disease progression despite prior treatments, which included imatinib and sunitinib.