Biotechnology company Genentech Inc. reported it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration to approve its drug Avastin as a secondary treatment for glioblastoma, an aggressive brain cancer.

Eisai Co announced that the U.S. Food and Drug Administration
(FDA) has approved a supplemental biologics license application (sBLA) for Ontak (denileukin diftitox), their solution for intravenous injection for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The full approval followed a priority review status.

ImClone Systems Inc announced it had filed a supplemental biologics license application (sBLA) for permission to market its Erbitux medicine as a first-line treatment for head and neck cancer. Erbitux is already approved as a colorectal cancer treatment and second line head and neck cancer.

Takeda Pharmaceutical Co, Japan's largest drugmaker, won the U.S. Food and Drug Administration´s (FDA) approval to promote its cancer drug Velcade – developed by now fully-owned Millenium Pharmaceuticals - for earlier treatment of multiple myeloma, the company announced. Velcade was originally approved as a second-line treatment, and is jointly marketed with Johnson & Johnson (J&J). Further details.

Merck KGaA announced it has filed for approval by the European health regulators (EMEA) to broaden the use of Erbitux to include first-line treatment of patients with head and neck cancer.

A U.S. Food and Drug Administration (FDA) advisory panel recommended approval to expand Amgen Inc.'s Enbrel (etenarcept) – jointly marketed with Wyeth - to treat children with moderate-to-severe psoriasis. The voting in favor won by a narrow margin of 7 to 5, with one abstention. Further details.

The Food and Drug Administration (FDA) has released documentation revealing its concern with post-approval study reports regarding life-threatening complications in children given Amgen Inc´s drug Enbrel for psoriasis.