CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for metastatic HSPC with BRCA1/2 mutations

“Patients with metastatic hormone-sensitive prostate cancer who carry BRCA1/2 mutations face a more aggressive disease with survival outcomes that are significantly shorter, compared to those without these mutations, with limited treatment options before their disease progresses to metastatic castration-resistant prostate cancer,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “Pending approval, the niraparib and abiraterone acetate dual action tablet will offer a targeted treatment strategy with the potential to address this urgent medical need earlier in the metastatic pathway, before the disease becomes more resistant.”

Share:

More News

Dr. Michael Ge, CEO of Kelun-Biotech said, “We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA® as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit

“We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade

“Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer,” said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. “With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and

“The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “With the completion of at least 12-month