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May 16, 2013

Bayer Prostate Cancer Drug Gains FDA Approval

  • Bayer HealthCare said yesterday it is weeks away from joining Algeta in bringing to the U.S. market their advanced prostate cancer drug Xofigo® (radium Ra 223 dichloride) following approval yesterday by FDA.

    The second new prostate cancer treatment approved by FDA in less than a year, Xofigo was approved for patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. Xofigo is also the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo in a Phase III trial.

    Bayer HealthCare and Algeta will co-promote Xofigo in the U.S, with Bayer holding exclusive marketing rights for the rest of the world. Bayer agreed in September 2009 to license Xofigo from Algeta, which discovered the drug. In return, Bayer agreed to pay Algeta up to $800 million—including $61 million up-front—plus tiered double-digit royalties on net sales in markets where there is no co-promotion, under a development and commercialization deal.

    Some 90% of men with CRPC are at risk of decreased OS after developing bone metastases, as bone is the most common site in the body to be affected by metastatic prostate cancer. Xofigo binds with minerals in bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues.

    "Xofigo has demonstrated an antitumor effect on bone metastases and will be an important addition to the treatment of this cancer," Oliver Sartor, M.D., medical director of the Tulane Cancer Center and North American Principal Investigator for the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, said in a statement.

    ALSYMPCA assessed the effects of Xofigo on OS of 809 men with symptomatic CRPC that spread to bones but not to other organs. An interim analysis showed Xofigo significantly improving OS by about three months, to a median OS of 14 months for Xofigo plus best standard of care, compared with 11.2 months with placebo plus best standard of care. The interim analysis also showed a delay in time to first SSE for patients treated with Xofigo vs. placebo.

    After ALSYMPCA, an updated analysis showed OS improvement, with a median OS of 14.9 months vs. 11.3 months. Most common reported side effects included nausea, diarrhea, vomiting, and peripheral edema.

    Xofigo was approved by FDA more than three months ahead of the product’s prescription drug user fee (PDUFA) goal date of August 14, and was reviewed under FDA’s priority review program. Xofigo, formerly called Alpharadin, received priority status just three months ago.

    Xofigo’s approval came nine months after FDA approved the prostate cancer drug Xtandi, co-marketed by Astellas Pharma and Medivation. Xtandi—also approved three months ahead of its PDUFA date of November 22, 2012—is indicated for men with metastatic CRPC that has spread or recurred, even with medical or surgical therapy to minimize testosterone, and who were previously treated with docetaxel.

    Also approved in recent years for prostate cancer have been troubled Dendreon’s pricey Provenge, which has failed to live up to lofty initial sales expectations; and Johnson & Johnson’s Zytiga, which racked up $961 million in sales last year, en route to blockbuster status. Also, Exelixis seeks to add a prostate cancer indication to its thyroid cancer drug cabozantinib, pursuing a pair of Phase III studies whose results are expected to be released next year.

    "It is encouraging to have a new treatment for men with castration-resistant prostate cancer who are dealing with bone metastases. Xofigo provides another new option to treat this cancer using a different approach," Jan Manarite, senior educational facilitator for the Prostate Cancer Research Institute, said in the statement. 


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