FDA approves new indication for Xtandi
pharmafile | September 11, 2014 | News story | Sales and Marketing | Astellas, FDA, Medivation, Xtandi, Zytiga, prostate
The FDA has approved Astellas Pharma and Medivation’s prostate cancer drug Xtandi (enzalutamide) for use in patients who have not received chemotherapy.
This new indication green light is based on the results of the Phase III PREVAIL trial, in which men receiving Xtandi showed a significant improvement in both overall survival and progression of their cancer compared to placebo groups.
The results also showed that the drug delayed the average time until the initiation of chemotherapy by 17 months.
Sales of Xtandi are split between Medivation and Astellas in the US, but Astellas is responsible for the regulation, manufacturing and sales of the drug elsewhere. This agreement entitles Medivation to receive $90 million in milestone payments triggered by the approval.
Xtandi is an oral androgen receptor inhibitor used to treat metastatic castration-resistant prostate cancer (CRPC). The FDA initially approved the drug back in August 2012, but only for use in men who had previously received chemotherapy.
In Europe the drug is still only permitted for use post-chemotherapy, but the FDA’s decision sets a precedent for a wider patient base that may help Xtandi keep pace with Johnson & Johnson’s Zytiga (abiraterone acetate), which is currently the market leader and was approved for pre-chemotherapy use in the EU last year.
The drug had previously only been approved by NICE for use in patients who had not received Zytiga, but this decision was overturned recently.
In addition, Xtandi is considered to be more convenient than Zytiga because the dose does not have to be reduced to prevent liver toxicity and it can be taken on a full stomach.
Xtandi is one of only a few treatment options available to men with advanced prostate cancer and is particularly useful because it can be taken at home. This and its proven ability to extend life have led to it being tipped as a blockbuster with $1-2 billion in peak sales.
George Underwood
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …
