Posts Tagged ‘Advanced Renal Cell Carcinoma’

Pazopanib – Two FDA Approvals, Many Impressive Results

Monday, December 17th, 2012

soft tissue sarcomaPazopanib, CAS number 635702-64-6, is an efficacious treatment for patients with advanced renal cell carcinoma, or RCC. As a type of cancer that begins in the cells of the kidneys, mainly in adults, Pazopanib is a reliable treatment in the class of medications called tyrosine kinase inhibitors. Pazopanib works by stopping or slowing the spread of cancer cells. Initially approved by the FDA on October 19, 2009, for the treatment of patients with advanced renal cell carcinoma, Pazopanib has now reached another milestone. On May 3, 2012 the FDA approved Pazopanib for the treatment of advanced soft tissue sarcomas. This approval is exciting, as it is the first new treatment option for this patient profile in several decades. The brand of Pazopanib is known as Votrient, which is marketed by GlaxoSmithKline.

pazopanibAs a tablet which is taken orally on an empty stomach once daily, Pazopanib should be taken at the same time each day. The approval of Pazopanib for patients with advanced soft tissue sarcoma is especially effective for patients who have previously undergone chemotherapy. The latest approval was based on a multicenter, double-blind, placebo-controlled and randomized trial known as PALETTE. The trial was conducted in patients with metastatic soft tissue sarcoma who had received prior chemotherapy treatment, including an anthracycline, and it involved 369 patients who were dosed with 800 milligrams of Pazopanib once daily or a placebo. The median treatment duration was 1.9 months for patients who received a placebo and 4.5 months for patients who were dosed with receiving Pazopanib Hydrochloride. There was a noteworthy improvement in progression-free survival for those patients who received Pazopanib, 4.6 months compared to 1.6 months for patients who were given a placebo. Additionally, there were no patients who received Pazopanib that did not demonstrate a response to this powerful drug. Adverse reactions ranged from fatigue to nausea and vomiting, but none were acutely severe.

The National Cancer Institute reported that in 2012 there will be approximately 65,000 Americans diagnosed with kidney cancer, and 14,000 deaths were to have attributed to this illness. Continued research and development is needed for this patient population, and LGM Pharma is ready to assist clients with this R&D. LGM Pharma provides the API Pazopanib, and offers clients complete support throughout the research and development process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

Axitinib Approved for Patients with Advanced Renal Cell Carcinoma

Monday, January 9th, 2012

axitinibAs of December 7, 2011 the Oncologic Drugs Advisory Committee voted to approve Axitinib CAS# 319460-85-0 (Inlyta) as a second-line treatment for patients with Advanced Renal Cell Carcinoma. This unanimous vote was based upon the findings of the phase 3 trial done in 2010, which compared Axitinib and Sorafenib. Axitinib, when compared to Sorafenib in clinical trials, was shown to significantly extend survival and disease progression.

Developed by Pfizer, Axitinib is a small molecule tyrosine kinase inhibitor. Phase 2 trials showed promise for patients with Breast Cancer, as Axitinib showed to inhibit tumor growth. Another trial, combining Axinitib with Gemcitabine initially showed improvement in patients with advanced pancreatic cancer. However, as of 2009 Pfizer announced that the results of this chemotherapy combination did not actually improve survival rates, when compared to the use of Gemcitabine alone. The trial was halted at that point.

Common side effects of Axitinib included diarrhea, hypertension, nausea and fatigue, of which all were considered manageable. Axitinib is an inhibitor for Vascular Endothelial Growth Factor receptors 1, 2 and 3, and hypertension is often considered to be a common side effect for these anti VEGF drugs. Reported dosage for trials of Axinitib were five milligrams, given twice daily.

LGM Pharma, an active pharmaceutical ingredient supplier, has built a reputation as being the “go to source” for hard to find API’s such as Axitinib, which is available on their website for R&D and drug development purposes.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.