Johnson & Johnson's Novel Prostate Cancer Drug Akeega Receives FDA Approval for BRCA-Mutated mCRPC

Janssen(JNJ.US) Janssen Division Announces FDA Approval of Oral Cancer Drug Akeega for Adult Combination Therapy in Certain Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Therefore, Akeega, which combines the PARP inhibitor niraparib with Janssen Pharmaceuticals' best-selling prostate cancer drug Zytiga, will be launched in the U.S. market for adult mCRPC patients with BRCA mutations confirmed by FDA-approved testing.

Data show that in 2023, prostate cancer is expected to cause 2.883 million new cases and 35,000 deaths, of which 10%-15% of mCRPC patients have BRCA gene alterations, a group with poor prognosis and shorter survival time.

FDA Approval of Akeega is Based on Janssen’s Phase 3 Magnitude Study, Which Showed that Akeega and Prednisone Reduced the Risk of Radiographic Progression-Free Survival by 47% in BRCA-Positive Patients Compared to the Placebo Control Group, a Statistically Significant Result.

Johnson & Johnson collaborates with Tesaro, Inc. to commercialize Akeega, the latter company was acquired in 2019.GSK(GSK.US) acquisition. Meanwhile, Zytiga generated $1.8 billion in global sales for Janssen Pharmaceuticals in 2022, representing a 23% decrease year-over-year.

Editor: Guo Mingyu