GlaxoSmithKline (GSK) recently announced that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11-2 in favor of Votrient (pazopanib) for advanced soft tissue sarcoma patients who have received prior chemotherapy. The committee felt that the benefits of Votrient in this indication outweigh the risks associated with it.
On June 4, 2011, Glaxo had reported positive data from a phase III trial of Votrient at the American Society for Clinical Oncology (ASCO). The PALETTE (PAzopanib ExpLorEd in SofT-Tissue Sarcoma) study was conducted in patients with advanced soft tissue sarcomas whose disease had progressed despite treatment with chemotherapy. Patients with gastrointestinal stromal tumours (GIST) and adipocytic sarcomas were not included in this trial.
The study data demonstrated that median progression free survival among patients receiving Votrient was 4.6 months compared to 1.5 months among those receiving placebo. However, overall survival was not statistically significant, with median overall survival for patients receiving Votrient and placebo being 11.9 months and 10.4 months, respectively.
Glaxo submitted a supplemental New Drug Application (sNDA) to the FDA for Votrient for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy in June 2011. A Marketing Authorisation Application was filed in Europe in July 2011. The FDA’s response should be out in the first half of 2012. Although the agency is not required to follow the committee’s advice, it usually does so.
Votrient is currently marketed worldwide for the treatment of patients with advanced renal cell carcinoma (RCC). It enjoys an 18% share of total prescriptions in the advanced renal cell carcinoma market in the US. Glaxo reported that Votrient sales are rapidly growing. Glaxo is also evaluating Votrient as a treatment for ovarian cancer.
We note that recently the ODAC voted 13-1 against Merck (MRK) and ARIAD Pharmaceuticals’ (ARIA) oncology candidate, ridaforolimus. Ridaforolimus is being evaluated as a maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy.
We currently have a Neutral recommendation on Glaxo. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
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