GlaxoSmithKline (GSK) 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 combination with Roche’s (RHHBY) 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 ongoing.
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 disease-free survival.
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.
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.
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