|
REGULATORY AGENCY ACTIONS
- Merck KGaA has submitted an application to the European Medicines
Agency (EMEA) to broaden the indication for cetuximab (ErbituxTM)
to include first-line treatment of patients with recurrent or metastatic squamous
cell carcinoma of the head and neck. The submission is based upon data from a 442-patient,
randomized phase III trial, the EXTREME study, which demonstrated that cetuximab
plus platinum-based chemotherapy significantly increased overall survival (OS).
The median OS for patients in the cetuximab plus chemotherapy arm was 10.1 months
compared to 7.4 months for those treated with platinum-based chemotherapy alone.
The application was submitted on June 24, 2008. Cetuximab has been licensed in the
European Union (EU) for use in combination with radiotherapy for locally advanced
squamous cell carcinoma of the head and neck since April 2006.
- On May 30, 2008 the European Medicines Agency (EMEA) recommended
approval of cetuximab as a first-line treatment in combination with chemotherapy
for patients with metastatic colorectal cancer. Merck KGaA states that recommendations
for marketing approval by the agency’s Committee for Medicinal Products for Human
Use (CHMP) are normally endorsed by the European Commission within a couple of months.
- On June 20, 2008 the U.S. Food and Drug Administration (FDA) approved
bortezomib (Velcade®, Millennium Pharmaceuticals, Inc., The Takeda Oncology Company,
and Johnson and Johnson Pharmaceutical Research and Development) for the treatment
of newly diagnosed patients with multiple myeloma. The approval was based on an
international, multicenter randomized trial in 682 previously untreated patients
with symptomatic multiple myeloma. Patients were randomized to receive either oral
melphalan (M) plus prednisone (P) or MP plus bortezomib. The primary endpoint was
time-to-progression (TTP) with secondary endpoints of OS, PFS, and RR. Eligible
patients were age ≥ 65 years. The trial was discontinued following a pre-specified
interim analysis that demonstrated a statistically significant improvement in TTP
with the addition of bortezomib to MP (median 20.7 months) compared with MP alone
(median 15 months) [HR 0.54, p=0.000002]. OS, PFS, and RR also were significantly
superior for the bortezomib-MP combination. The treatment was well tolerated with
no unexpected toxicity attributable to the addition of bortezomib
|
|