Medivation Inc. and partner Astellas Pharma Inc. are looking to get the label for their prostate cancer treatment, Xtandi, expanded into the chemo-naïve patient population. The companies have filed a supplemental New Drug Application (sNDA) seeking FDA approval for Xtandi for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.
The sNDA is based on data from the phase III PREVAIL study. Results from this study were pretty impressive with Xtandi reducing the risk of death by 29% compared to placebo. Moreover, the risk of radiographic progression or death was cut by 81% in the Xtandi arm. A 17-month delay in the time to initiation of chemotherapy was observed in the Xtandi arm.
Medivation also reported that most of the men with soft tissue metastatic disease had objective responses in the Xtandi arm compared to placebo (58.8% versus 5%) – complete response was observed in 19.7% of patients in the Xtandi arm compared to just 1% in the placebo arm.
The median time to PSA progression was extended from 2.8 months in the case of placebo to 11.2 months in the case of Xtandi. About 78% of patients in the Xtandi arm saw a PSA decline of ≥50% compared to less than 4% in the placebo arm.
Xtandi is currently approved for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. Medivation and Astellas intend to apply for EU approval for the chemo-naïve indication later this year.
Expansion into the pre-chemo setting will be a major positive for Medivation. The 17-month delay in the time to initiation of chemotherapy should help Xtandi gain share once it is approved for the pre-chemo patient population.
Medivation is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the biotech sector include companies like Gilead Sciences Inc. (GILD - Free Report) and Alexion Pharmaceuticals, Inc. (ALXN - Free Report) . Both carry a Zacks Rank #1 (Strong Buy).