It appears that Roche is not in a hurry to file for 3rd line. Perhaps they don't want to mess up the 2nd-line and 1st-line pivotal trials. ONce T-DM1 is approved, those patients randomized to control arm would be clamoring for it upon disease progression.
Nevertheless, Roche seems enthuesiastic about T-DM1. Good thing for IMGN share holders.
FDA Approves Chemo-Free Tykerb+Femara Regimen in First-Line Breast Cancer
[This is a new indication for GSK’s Tykerb, which works via the HER1/HER2 pathways; NVS’ Femara is an aromatase inhibitor that operates via the estrogen pathway. As one would expect, the Tykerb + Femara cocktail is indicated only for HER2+/estrogen+ cancers. The study on which the approval is based tested Femara ± Tykerb, so there was no comparison to any regimen containing Herceptin.]
›GSK's TYKERB Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
Friday January 29, 2010, 7:46 pm EST
PHILADELPHIA, Jan. 29 /PRNewswire/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.
TYKERB is now indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
"This combination of TYKERB plus Femara® is an example of advancing science and improving patient care. This regimen attacks two specific receptors that drive cancer growth," said Paolo Paoletti, Senior Vice President, GSK Oncology R&D. "Women battling this disease now have the opportunity to delay the use of traditional cytotoxic-chemotherapy, which is an exciting possibility for them."
Between 25 and 30 percent of breast cancers overexpress HER2 receptors and 60 to 70 percent of all breast cancer cases in Europe and the U.S. are HR positive.
TYKERB was already indicated in combination with Xeloda® (capecitabine) for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
TYKERB, known as TYVERB in European markets, is currently being reviewed by the EMEA for a comparable indication through a supplemental marketing authorization.
About the study
In the double-blind, placebo-controlled study, which enrolled 219 women diagnosed with post-menopausal, HR-positive and HER2-positive metastatic breast cancer, women treated with lapatinib and letrozole experienced a 5.2 month increase in median progression-free survival (PFS) compared to women treated with letrozole alone.
The most common (greater than or equal to 20%) adverse reactions during treatment with TYKERB plus letrozole were diarrhea, rash, nausea and fatigue. The safety profile of TYKERB was consistent with previously reported results from trials of TYKERB in the advanced or metastatic breast cancer population.
About TYKERB (lapatinib)
Lapatinib is an oral small-molecule inhibitor of the HER2/ErbB2 tyrosine kinase receptor. Stimulation of HER2/ErbB2 is associated with cell proliferation and with multiple processes involved in tumor progression and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.
Lapatinib, in combination with capecitabine, is approved in 92 countries. On March 13, 2007, the U.S. FDA approved lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2/ErbB2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. On June 10, 2008, the European Commission granted a conditional marketing authorization for lapatinib in all 27 European Union (EU) member states. Other countries in which lapatinib is approved for marketing include Australia, India, Brazil, Russia, Switzerland, Turkey, South Korea, Taiwan and others around the world. Registration dossiers for lapatinib have been filed in Canada, China, Japan, Mexico and a number of countries in Latin America, Middle East, Africa and Asia Pacific.‹
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