Janssen Research & Development, a subsidiary of Johnson & Johnson, announced FDA approval for the expanded use of Zytiga (abiraterone acetate) in treating metastatic castration-resistant prostate cancer (mCRPC). This approval now allows Zytiga to be prescribed as a first-line treatment, even before chemotherapy is considered.
Significance of the Approval
Previously, Zytiga was only approved for mCRPC patients who had already undergone docetaxel-based chemotherapy. The new indication broadens the treatment landscape, providing an alternative for patients who may not be suitable candidates for chemotherapy or for whom chemotherapy has failed. This offers a significant advantage, potentially improving outcomes and quality of life for a larger population of men with mCRPC.
Prostate Cancer Burden
Prostate cancer is the most frequently diagnosed cancer in men in the U.S., excluding skin cancers. In 2012, the American Cancer Society estimated that over 28,000 men would die from the disease, making it the second leading cause of cancer death among men, behind lung cancer. Approximately 35,000 new cases of mCRPC are diagnosed each year, highlighting the urgent need for effective treatment options.
Ongoing Expansion Efforts
Janssen is actively pursuing further approvals for Zytiga's expanded usage in other regions. The company has already received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, signaling potential future availability in Europe.
