) recently announced the withdrawal of the US marketing application
for its cancer drug, Tykerb (Tyverb in the US, generic name:
lapatinib). Glaxo was seeking approval for the use of Tykerb in
) Herceptin (trastuzumab) for the treatment of patients with
metastatic human epidermal growth factor receptor 2 (HER2) positive
breast cancer who have received prior Herceptin therapy.
The decision to withdraw the application was taken after the US
Food and Drug Administration (FDA) raised issues regarding the use
of Tykerb, which Glaxo was unable to address with currently
available data. There is an ongoing study evaluating the
combination of Tykerb with Herceptin. The company plans to pursue
regulatory approval once data is available from this trial.
The company had submitted regulatory applications in the US and EU
for Tykerb/Tyverb in February 2012. Regulatory review in EU is
We note that the company has received a string of blows in it label
expansion efforts centered on Tykerb. In February 2012, Glaxo
withdrew its EU marketing application for the use of Tyverb in
combination with paclitaxel for the treatment of patients with
metastatic HER2 positive breast cancer.
The decision to withdraw the application was taken after the
Committee for Medicinal Products for Human Use (CHMP) indicated
that it is difficult to analyze the risk-benefit properly due to
the lack of a head-to-head comparison between Tyverb plus
paclitaxel with Herceptin plus paclitaxel.
In September 2011, Glaxo had announced the termination of a study
arm evaluating Tykerb in patients with HER2 positive early stage
breast cancer. The study arm was halted after an independent data
monitoring committee indicated that Tykerb was unlikely to
demonstrate non-inferiority to Herceptin, with respect to
Tykerb is currently approved in combination with Roche's Xeloda
(capecitabine) for treating patients suffering from advanced or
metastatic HER2 positive breast cancer who have received prior
therapy including an anthracycline, a taxane, and Herceptin. It is
also approved in combination with letrozole for postmenopausal
women with hormone receptor positive metastatic breast cancer that
overexpresses the HER2 receptor.
Breast cancer is the most prevalent form of cancer in women.
Worldwide, approximately 1.4 million new breast cancer cases are
diagnosed annually. HER2 positive breast cancer accounts for
approximately 15%-20% of total breast cancer cases.
Currently approved products specifically indicated for this type of
cancer include Herceptin and Tykerb. We note that Herceptin
generated sales of approximately $4.6 billion (CHF 5,253 million)
while Tykerb generated sales of $372 million for the 12 months
ending December 2011.
A new entrant in this market is Roche's Perjeta (pertuzumab),
which was approved last month for treating HER2-positive metastatic
breast cancer in patients who have not received prior anti-HER2
therapy or chemotherapy. Perjeta was approved for use in
combination with Herceptin and docetaxel chemotherapy.
GLAXOSMITHKLINE (GSK): Free Stock Analysis
(RHHBY): ETF Research Reports
To read this article on Zacks.com click here.
We are disappointed by the withdrawal of the supplemental New Drug
Application (sNDA) for Tykerb as we believe that a delay in the
expansion of Tykerb's label will lower Glaxo's chances of
penetration into this lucrative segment.
We currently have a Neutral recommendation on Glaxo. The stock
carries a Zacks #4 Rank (Sell rating) in the short run.