[CHMP (like ODAC) positive opinion for Tarceva in EU]
>>MELVILLE, N.Y.--(BUSINESS WIRE)--June 27, 2005--OSI Pharmaceuticals, Inc. (NASDAQ:OSIP - News) announced today that its ex-U.S. partner for Tarceva® (erlotinib), Roche, received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending approval of Tarceva for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is an oral tablet indicated for daily administration and was approved in the U.S. for NSCLC in November 2004. Following the CHMP recommendation, an approval decision for Tarceva by the European Commission is anticipated within 90 days.
"The CHMP recommendation is an important milestone toward making Tarceva available for lung cancer patients throughout the European Union," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We congratulate our colleagues at Roche on their progress and continue to project the launch of Tarceva in the EU during the final quarter of 2005."
"This decision is proof of the impressive survival benefit that Tarceva offers patients with late stage lung cancer," said William M Burns, CEO Division Roche Pharmaceuticals. "This brings new hope to lung cancer patients who have currently very limited treatment options."
The CHMP has recommended that Tarceva is indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with EGFR-negative tumors.
The CHMP recommendation is based on data from a pivotal Phase III study, Trial BR.21, which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. As in the U.S. label, no mandatory testing for EGFR is required in the CHMP recommendation.
About NSCLC
Lung cancer is the most common cancer worldwide with 1.2 million new cases annually with someone, somewhere dying of the disease every 30 seconds. NSCLC accounts for almost 80 percent of all lung cancer cases and there are few treatment options available. There are an estimated 370,000 people suffering with lung cancer each year in Europe.
About Tarceva
Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in non-small cell lung cancer (NSCLC) and other solid tumors. HER1, also known as EGFR, is a component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. Tarceva is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC as a single agent.
Tarceva was approved by the U.S. Food and Drug Administration in November 2004 and is an oral tablet indicated for daily administration for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Results from two earlier large, randomized, placebo-controlled clinical trials in first-line advanced NSCLC patients showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting.
For Tarceva full prescribing information, please call 1-877-TARCEVA or visit tarceva.com.
Tarceva Safety Profile
In the pivotal NSCLC trial, the most common adverse reactions in patients receiving Tarceva were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 9 and 6 percent of Tarceva-treated patients, respectively. Rash and diarrhea each resulted in discontinuation of 1 percent of Tarceva-treated patients. Dose reduction for rash and diarrhea was needed for 6 and 1 percent of patients, respectively. Historically, there have been infrequent reports of serious interstitial lung disease (ILD), including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumors. In the pivotal trial in NSCLC, severe pulmonary reactions, including potential cases of interstitial lung disease, were infrequent (0.8 percent) and were equally distributed between treatment arms. The overall incidence of ILD in Tarceva-treated patients from all NSCLC studies was approximately 0.7 percent. <<
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So does anyone here think Avastin and Sutent will be kicking Tarceva's butt?
TIA & Cheers, Tuck |
