[Updated: 3:10 pm ET] The FDA usually waits until the last-minute deadline to finish its review of whether to approve a new drug for sale in the U.S. But the agency has given San Francisco-based Medivation clearance to start selling its prostate cancer drug today—about three months ahead of its statutory deadline.
Medivation (NASDAQ: MDVN) and Japan-based Astellas Pharma got the go-ahead today to start selling enzalutamide (Xtandi)—formerly MDV3100—as a drug for patients whose prostate cancer has spread even after the usual hormone-blocking treatments and chemotherapy have been given. The agency had agreed to a faster-than-usual six-month review of this treatment—which it sometimes provides to groundbreaking medicines—but regulators found the evidence so compelling in this case that they didn’t need to wait until the legal deadline of Nov. 22. The new drug, Medivation’s first, is expected to be available on the market in mid-September.
The new Medivation drug passed its final-stage clinical trial with flying colors. In a study of about 1,200 patients, it helped patients live a median time of 18.4 months compared with 13.6 months for those on a placebo; it showed an ability to slow the spread of tumors, and it improved quality of life scores for 43 percent of patients, compared with 18 percent on the placebo. That performance got people buzzing at last June’s American Society of Clinical Oncology conference, and speculating about how well the drug might perform in prostate cancer patients with less dire prognoses. About 30,000 men in the U.S. die each year from prostate cancer, according to the American Cancer Society.
“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” said Richard Pazdur, the director of the FDA’s cancer drug office, in a statement. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”
Medivation’s co-founder and CEO David Hung added in a statement that, “today’s approval marks a significant accomplishment for Medivation. We are proud to be in a position to offer a new treatment, Xtandi, for this patient population for which there is a significant unmet medical need.”
Medivation has set the wholesale price of the drug at $7,450 a month, and the median patient got the drug in Medivation’s pivotal trial for about eight months, Hung said on a conference call with investors. The price was set at that point based on the drug’s safety and effectiveness; market research the company conducted with physicians, payers, and patients; and comparisons with other orally-delivered cancer drugs, he added.
The Medivation drug uses a new scientific mode of action that seeks to block the binding of male sex hormones (androgens) to the androgen receptor, which is supposed to interfere with a key process that drives tumor cell growth. The most common reported side effects in the company-sponsored trials included weakness or fatigue, back pain, diarrhea, joint pain, according to an FDA statement. About 1 percent of patients on the drug in clinical trials reported seizures, and quit taking the drug, the FDA said.
Medivation will now be in position to compete with Johnson & Johnson’s oral pill abiraterone (Zytiga), as well as the injectable immunotherapy developed by Seattle-based Dendreon (NASDAQ: DNDN). Although Medivation’s initial FDA approval is for patients who have essentially run out of options after chemotherapy failed, and Medivation can’t market it for any other use, doctors can choose to prescribe it “off-label” for patients with less severe forms of the disease. Medivation is currently conducting a clinical trial to prove the drug offers a benefit for patients in the “pre-chemo” setting, where many more people are likely to seek treatment, and the market opportunity is more lucrative.
Shares of Medivation have been booming virtually all year long, and the faster-than-expected FDA approval didn’t really change perceptions. The stock climbed $1.37 a share to $98.79 at 1:08 pm Eastern time.
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