Johnson & Johnson Receives Two Cancer Drug Approvals
The US FDA approved Akeega and Talvey late last week. Phase 3 trials validated Akeega's use in the treatment of patients with BRCA-positive prostate cancer. Talvey is authorized for patients with heavily pretreated multiple myeloma.
Both drugs were developed by Janssen of Johnson & Johnson. Akeega received approval following a phase 3 study, while Talvey received accelerated approval following a phase 2 study.
Akeega
Prostate cancer is one of the most common cancers in the US, with an estimated 288,300 new cases and nearly 35,000 deaths expected in 2023. Patients with BRCA-positive mCRPC are more likely to have aggressive disease and may experience poor outcomes and a shorter survival time.
Akeega (niraparib and abiraterone acetate) is the first dual-action tablet given with prednisone for treating adult patients with deleterious or suspected deleterious BRCA-positive mCRPC.
"The approval of Akeega brings an important treatment option to patients with prostate cancer as they consider their road ahead, and it also highlights the importance of genetic testing and precision medicine for this disease,” said Shelby Moneer, Vice President of Patient Programs and Education, Zero Prostate Cancer.
Talvey
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Multiple myeloma is the third most common blood cancer and remains an incurable disease. In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the US and more than 12,000 people will die from the disease.
Talvey (talquetamab-tgvs) is a bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. It was approved under accelerated approval based on response rate and durability of response, with a continued approval contingent on further studies.
Ajai Chari, Director of Multiple Myeloma Program, Professor of Clinical Medicine at the University of California, San Francisco says, “Patients at this stage of disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.”
