) recently announced the withdrawal of the marketing authorization
application (MAA) to the European Medicines Agency (EMA) for
Erbitux (cetuximab) as the European regulatory authorities had
asked the company to furnish additional data.
Merck KGaA was looking to get Erbitux approved for an additional
indication. The company was seeking European approval of the drug,
combined with standard first-line platinum-based chemotherapy in
patients suffering from advanced or metastatic non-small cell lung
cancer (NSCLC) with high epidermal growth factor receptor (EGFR)
We note Erbitux is currently approved and marketed in the US and
EU for the treatment of patients with colorectal cancer and
squamous cell carcinoma of the head and neck (SCCHN). The
withdrawal of the MAA for the additional indication does not
undermine the proven efficacy of the drug for the approved
Earlier, in July 2012, Merck KGaA announced that Erbitux failed
to achieve its primary endpoint in the phase III EXPAND trial,
conducted in patients with advanced gastric cancer. Results showed
that Erbitux plus cisplatin and capecitabine failed to
significantly increase progression-free survival (PFS) in patients
suffering from advanced gastric cancer.
Erbitux was originally developed by ImClone LLC, which is now a
wholly-owned subsidiary of
Eli Lilly and Co.
). Merck KGaA has the right to market Erbitux outside the US and
Canada. The drug is jointly developed and marketed by Eli Lilly and
Bristol-Myers Squibb Co.
) in the US, Japan and Canada.
Meanwhile, Merck KGaA provided an update on its oncology
candidate, TH-302. The company and partner
Threshold Pharmaceuticals, Inc.
) intend to commence a randomized phase III study on the candidate.
The study will evaluate TH-302 as a first-line therapy in patients
suffering from pancreatic cancer.
We remind investors that in February 2012, Merck KGaA presented
encouraging data from an open-label phase IIb study which evaluated
TH-302, in combination with Eli Lilly's Gemzar, for treating
patients suffering from advanced pancreatic cancer.
The study met its primary endpoint by achieving a 63%
improvement in PFS in patients treated with TH-302 and Gemzar in
comparison to Gemzar alone.
Merck KGaA currently carries a Zacks #2 Rank (Buy rating) in the
BRISTOL-MYERS (BMY): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis
(MKGAF): ETF Research Reports
THRESHOLD PHARM (THLD): Free Stock Analysis
To read this article on Zacks.com click here.