Bayer announced on February 25, 2013 a new approval by the FDA for the powerful cancer drug regorafenib. Known as the brand name Stivarga, this approval is specifically for patients with gastrointestinal stromal tumor (GIST) that is unresectable. Regorafenib, CAS number 755037-03-7, is a last option treatment for patients with GIST who have metastatic cancer that is unresponsive to first line treatments approved by the FDA, like imatinib (Gleevac) and sunitinib (Sutent). This new indication for regorafenib (Stivarga) for patients with GIST is based on data from a phase lll trial coined GRID, or GIST – Regorafenib In Progressive Disease. Patients in this important trial demonstrated an improved progression-free survival when taking regorafenib as compared to those patients who received a placebo. All patients enrolled in the study, whether they received regorafenib or a placebo received best supportive care, or BSC, as well. For clinical trial participants who were administered regorafenib (Stivarga) the median progression free survival was 4.8 months, versus 0.9 months in the placebo group. Risks of this formidable treatment include hepatoxicity, infection and a host of other adverse effects. However, the risks of taking regorafenib cannot be matched by the benefit of extended life for patients.
Regorafenib was previously approved by the FDA on May 23, 2012 to treat patients with metastatic colorectal cancer. As a powerful treatment with both antiangiogenic and antineoplastic activity, regorafenib is unique in that it binds to and inhibits the vascular endothelial growth factor receptors 2 and 3, as well as Raf kinases. The novel ability of regorafenib to inhibit tumor angiogenesis and tumor cell proliferation makes this new FDA indication and approval for patients with GIST not surprising. The initial approval of regorafenib for unresectable colon cancer was based on the Phase III CORRECT trial, which was completed by Bayer. The CORRECT study was an international, randomized, double-blind, and placebo-controlled trial which consisted of 760 participants. All of the clinical trial participants had unresectable, metastatic colorectal cancer that had progressed despite standard therapies within three months of time. The patients received either regorafenib plus supportive care or a placebo plus supportive care. The treatment cycles consisted of 160 mg of regorafenib, or a matching placebo, once daily for three weeks in a row, and one week off. Survival rates improved for 29 percent of the patients who received regorafenib, and there was a median overall survival of 6.4 months, as compared to a 5 month survival for patients who received the placebo.
Regorafenib has proven to be crucial for the treatment of both metastatic colorectal cancer and unresectable gastrointestinal stromal tumor. LGM Pharma offers API Regorafenib for research and development purposes. Clients can be assured of quality products and continuous support throughout the R&D process.
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The administration of trastuzumab in combination with or following chemotherapy has proven to be life saving for scores of patients with early stage HER2 gene amplification breast cancer. Oncology Practice reported in mid- December 2012 that women who received paclitaxel and trastuzumab after anthracycline chemotherapy for HER2-positive breast cancer had roughly a 40% less risk of dying from the disease. These extremely encouraging statistics compared those patients who were administered paclitaxel and trastuzumab after anthracycline chemotherapy with those patients who were given only paclitaxel. This pair of landmark clinical trials assessed the risk of death by the ten year mark after initial treatment. Theranostics also play a significant part in the utilization of trastuzumab. Known as the brand name Herceptin, researchers are currently exploring the use of theranostics to individualize patient care and treatment. Defined as diagnostics that are closely tied to a specific drug treatment, theranostics are an effectual part of testing and treatment for patients who are HER2 positive. If the patient is subsequently tested and diagnosed as HER-2 positive, a targeted treatment plan is implemented using trastuzumab. The advent of developing both diagnostic tests and targeted therapeutics in a collaborative manner is quickly becoming an integral option for individualizing patient treatment. Genentech’s Herceptin and DakoCytomation’s HercepTest are examples of this specific process in action, however, further research and development is greatly needed. Companies responding to this need can rest assured that LGM Pharma supplies trastuzumab, and other Monoclonal Antibodies (mAbs), with their complete support throughout the research and development process.
In addition to theranostics, strides are being made in gene identification and cancer risk. Oncology Nurse Advisor published an article on December 27, 2012 which offered exciting news regarding the genetic impact and cancer risk for patients. Results from a pivotal study led by Dr. Edith Perez, and researchers at the Mayo Clinic Comprehensive Cancer Center, announced that 25 genes have been identified that are considerably associated with a positive outcome, when the use of trastuzumab and chemotherapy are used concurrently in treatment. This eye opening study is thought to be the first to use gene expression profiling for predicting outcomes for trastuzumab as part of adjuvant breast cancer therapy. Trastuzumab is dosed based on height, weight, patient health and the type of cancer being treated. Intravenous infusion is the typical method of delivery, and the first dose is usually given over a 90 minute time period. As a 
