Bristol-Myers Squibb is hoping to file at least one and up to three new oncology drugs with the US Food and Drug Administration in 2007.
Robert Kramer, the firm’s vice president of oncology and immunology drug discovery, said the company firstly plans to file a marketing application for ixabepilone for breast cancer next year.
This will be followed by applications for ipilimumab for melanoma, which was recently granted fast-track status by the FDA and is being developed in collaboration with Medarex, and vinflunine for bladder cancer. Filings for the latter two treatments are anticipated for either late 2007 or early 2008.
B-MS also noted that it expects results from two Phase III trials testing Erbitux (cetuximab) as a first-line treatment for colorectal and pancreatic cancer to be completed next year. The drug, which is manufactured by Imclone Systems, is currently approved for head and neck cancer as well as colorectal cancer patients who do not respond to first-line therapies.
Finally, B-MS noted that Sprycel (dasatinib), which was recently approved for the treatment of chronic myeloid leukemia who are not responding to Novartis’ Gleevec (imatinib), is also being developed in a number of new indications including breast cancer.
Mr Kramer said that B-MS currently has 20 cancer compounds in development, and the company will host a conference call on December 18 to review data presented at the recent American Society of Hematology meeting for several oncology and cardiovascular compounds.
