ODAC votes on Celltech's MAb

An FDA advisory committee voted 11-2 today to recommend accelerated approval of Mylotarg (gemtuzumab zogamicin) for patients over 60 years old with relapsed CD33+ acute myeloid leukemia. Mylotarg was developed by Celltech (LSE:CCH; CLL) in partnership with Wyeth-Ayerst.

Accelerated approvals are based on surrogate end points and are contingent on demonstration of clinical efficacy in post-marketing studies. ...