BY OUR PHARMA CORRESPONDENT
11 August, 2005: A special panel of cancer experts will review the use of the drug combo Tarceva (erlotinib) plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in US this week.
The Oncologic Drugs Advisory Committee (ODAC) panel formed by the US FDA, to advise the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer will review the efficacy of the drug duo in cancer in patients who have not received any previous treatment, OSI Pharmaceuticals, Inc. announced.
In July 2005, the FDA had assigned priority review status for Tarceva after accepting for filing for the supplemental New Drug Application (sNDA) for use of Tarceva plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer.
Based on this priority review status, the FDA has six months from receipt of the sNDA data, or until November 2, 2005, to take action on the sNDA filing. Tarceva is the only agent shown to provide a statistically significant survival benefit in patients treated in first-line locally advanced or metastatic pancreatic cancer in combination with gemcitabine chemotherapy, the company release said.
Tarceva was approved by the FDA in November 2004 and is an oral tablet indicated for daily administration 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 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.
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 per cent, the OIS release said.
The American Cancer Society predicts that in 2005 about 32,180 people in the United States will be diagnosed with pancreatic cancer and about 31,800 will die of the disease. Although pancreatic cancer accounts for 2 per cent of new cancer cases in the United States, it is the fourth leading cause of all cancer deaths.
OSI Pharmaceuticals is into discovering, developing and commercializing novel pharmaceutical products that extend life or improve the quality of life for cancer and diabetes patients worldwide. The company operates through two business teams, (OSI) Oncology and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI's flagship product, Tarceva, is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients. OSI markets Tarceva through collaborations with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world.
In addition to Tarceva, (OSI) Oncology exclusively markets Novantrone (mitoxantrone concentrate for injection) for its approved oncology indications and markets Gelclair(R) Bioadherent Oral Gel for the relief of pain associated with oral mucositis. The research and development pipeline consists of novel molecularly targeted anti-cancer agents focused on signal transduction pathways involved in cell proliferation, apoptosis and angiogenesis. The most advanced of these programs, targeting the co-inhibition of c-kit and VEGFR, has two candidates in development.
BY OUR PHARMA CORRESPONDENT