Following its approval by the U.S. Food and Drug Administration (FDA), the generic abiraterone acetate 250mg tablets will be available for the treatment of men with metastatic castration-resistant prostate cancer (CRPC).
This new generic product will be sold in 120 tablet-count bottles, and is recommended in combination with a steroid medication like prednisone or methylprednisolone.
“The approval of generic abiraterone is … significant for our organization as it continues to fill our portfolio with important products, most specifically those used in the oncology class,” Seshu Akula, president of North America generics at Novadoz, said in a press release.
“These products offer great value to patients and our customers, and continue to build on Novadoz’s successful entrance in the U.S market,” he added.
Therapies that lower male sex hormones — required for prostate cancer to survive and grow — are a mainstay of therapy for advanced prostate cancer. However, most men will acquire resistance to such approaches.
This often happens because the receptor for these hormones, called the androgen receptor, becomes constantly active, even in the absence of androgens. In such cases, the cancer is called castration-resistant.
Therapies that inhibit, or block the androgen receptor — such as Pfizer and Astellas‘ Xtandi and Janssen‘s Zytiga — have largely improved the overall survival of prostate cancer patients. Those treatments are now approved for mCRPC patients in the U.S. and Europe.
Zytiga – and, by extension, the generic abiraterone acetate version – were approved based on two randomized Phase 3 clinical trials (NCT00638690 and NCT00887198), in which abiraterone acetate was compared with placebo in men with metastatic CRPC.
The first study enrolled 1,195 patients who had received prior Taxotere (docetaxel) chemotherapy. Participants were randomly selected to receive 5 mg prednisone twice daily in combination with 1,000 mg abiraterone acetate daily, or prednisone plus a placebo, until their disease worsened, or toxicity issues appeared.
In the trial, abiraterone acetate reduced the risk of death by 35%. Those on the active treatment lived a median of 14.8 months, compared with 10.9 months for those on placebo.
In a second Phase 3 study, researchers evaluated the impact of long-term treatment with abiraterone acetate in metastatic CRPC patients who had not been previously exposed to chemotherapy.
In this setting, the treatment also extended overall survival, to 34.7 months, as compared to the placebo, at 30.3 months. Overall, the treatment reduced the risk of death by 19%.
Most common adverse reactions were fatigue, joint pain, high blood pressure, nausea, tissue swelling, hot flush, diarrhea, vomiting, upper respiratory infection, cough, headache, and low potassium blood levels.
“Since we have experienced early success supplying generics in a reliable and consistent basis with our customers, we are confident in our efforts to achieve additional success with Abiraterone 250mg tablets,” said Tom DeStefano, vice president of sales and marketing at Novadoz.