Medivation has added another set of stellar data on enzalutamide, its promising prostate cancer treatment now up for a priority review at the FDA. New late-stage results published in the New England Journal of Medicine indicate that advanced stage, therapy-resistant patients in the drug arm survived 5 months longer than the control group.
Investigators hammered hard on evidence of improved quality of life for patients and indications that the drug will work in pre-chemo patients--all key points as Medivation ($MDVN) and its partner Astellas plan to build a $1 billion to $2 billion-a-year franchise amid intense competition.
"This approach represents a much more potent and effective means of targeting the androgen receptor than possible with previously available agents," says study co-author Thomas Flaig, associate professor of medicine at the University of Colorado School of Medicine. "While this study examined the effect of adding Enzalutamide to standard androgen deprivation therapy, future studies could explore a single agent approach with this drug to treat prostate cancer. Another major study to look at this pre-chemotherapy activity is underway."
Enzalutamide, probably still better known to FierceBiotech readers as MDV3100, will likely come out of the marketing gate competing with Johnson & Johnson's ($JNJ) Zytiga--the hot new drug that also helps douse the testosterone-fueled advance of prostate cancer--among post-chemo patients. Both are avidly pushing upstream, though, to reach patients with an earlier stage of the disease. And Zytiga's success followed by enzalutamide's promise is crimping expectations for Dendreon's ($DNDN) Provenge, which has floundered badly since being approved. Medivation is looking for a relatively swift approval with a market launch in early 2013.
Howard Scher, chief of the genitourinary oncology service at Memorial Sloan-Kettering Cancer Center in New York City, tells HealthDay that the Phase III numbers bode well for enzalutamide in a pre-chemo population. A handful of seizures were noted in the study, one of the most serious adverse events, but Medivation feels confident that the side effect profile is particularly promising for its therapy.
Enzalutamide has a PDUFA deadline of November 22.
- here's the press release
- get the story from HealthDay
- see the report from the Daily Mail
Special Report: Enzalutamide (formerly MDV3100) – Top 10 Late-Stage Cancer Drugs – 2012
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