Johnson & Johnson subsidiary Janssen-Cilag International NV has applied to the European Medicines Agency (EMA) to increase the usage of AKEEGA®, its cancer medication. To utilize the medication in adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) who have particular genetic changes known as HRR gene mutations, the business is requesting permission.
The Phase 3 AMPLITUDE study’s encouraging findings served as the foundation for the application. When compared to the current standard of therapy, the trial demonstrated that a dual-action tablet containing niraparib and abiraterone acetate considerably delayed the progression of cancer and the worsening of associated symptoms.
Patients with HRR gene mutations, a population that frequently experiences worse results, are the focus of this novel therapy strategy, which targets the underlying biology of the illness. It was discovered that the combination therapy’s safety profile aligned with its present application in patients with castration-resistant prostate cancer that had spread.
To fight the illness, AKEEGA® combines two different modes of action. Abiraterone acetate is a CYP17 inhibitor that prevents the synthesis of androgens that promote the growth of prostate cancer, whereas niraparib is a highly selective inhibitor of poly (ADP-ribose) polymerase (PARP) that targets DNA repair pathways. The combination’s safety profile aligned with the separate agents’ established characteristics.
AKEEGA® would be the first dual-action tablet in the European Union to combine a PARP inhibitor with a CYP17 inhibitor for this particular patient population if this additional indication is authorized. For a population of patients with a high level of unmet medical need, this would be a major breakthrough in precision medicine.
Last Modified:
Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
Published Literature: https://www.sciencedirect.com/science/article/abs/pii/S0168160523000648
