Oasmia barrels toward FDA filing after ovarian cancer drug clears PhIII

FDA sign

Oasmia Pharmaceutical ($OASM) has posted top-line data from a Phase III trial designed to support a filing for approval with the FDA. The study found that Oasmia’s formulation of paclitaxel was as effective in patients with ovarian cancer as Taxol in terms of overall survival, an outcome that adds to existing evidence of its noninferiority in terms of progression-free survival.

Uppsala, Sweden-based Oasmia administered its paclitaxel formulation, which is branded as Paclical or Apealea depending on the region, or Taxol to 789 patients with epithelial ovarian cancer. Patients in both arms also received carboplatin. The overall survival data for both arms are very similar. Taxol was associated with an overall survival of 24.8 months, compared to 25.7 months among patients that received Oasmia’s drug.

The similarity is unsurprising given that both arms of the clinical trial administered the same active ingredient, paclitaxel. “It was expected that the analysis of the OS data would show non-inferiority and confirmation of the PFS results, two key factors for why we believe Apealea is an alternative to the presently available treatments of ovarian cancer,” Oasmia VP of Clinical Development Margareta Eriksson said in a statement.

Oasmia put the progression-free survival results to the European Medicines Agency in a marketing approval filing earlier this year, a submission that will now be enhanced with the addition of the overall survival data. Oasmia will also parcel up the overall survival data and file it with the FDA, setting it on a path it thinks will lead to the approval of its paclitaxel formulation in the U.S. by the end of 2016/2017.

If successful, Oasmia will need to differentiate its product from Taxol, something that cannot be done with efficacy data alone. Apealea’s edge, as Oasmia sees it, stems from its use of its excipient XR-17 to encapsulate paclitaxel. The formulation is free from Cremophor EL, an excipient associated with allergic reactions. Taxol, which is formulated with Cremophor EL, necessitates pretreatment with steroids and antihistamines to cut the risk of allergic reactions.

Participants who received Apealea “did not receive such treatment to the same extent,” Oasmia said. The expectation is that this will deliver a more favorable side effect profile, notably by cutting the risk of hypersensitivity reactions. However, Oasmia’s statement regarding the overall survival data makes no mention of the safety profile of either of the tested treatments or incidence of hypersensitivity reactions. Earlier analyses found no hypersensitivity reactions among patients treated with Oasmia's formulation.

- read the statement