FDA approves Akeega for BRCA-positive metastatic prostate cancer

for the treatment of BRCA-positive metastatic castration-resistant prostate cancer.

The approval makes Akeega the first and only dual action tablet combining a poly polymerase inhibitor withThe FDA approval is based on positive results from the randomized multicenter phase 3 MAGNITUDE study. Patients treated with the combination of Akeega plus prednisone had a statistically significant risk reduction in radiographic progression-free survival . At a median follow-up of 24.

There was also improvement seen in the secondary end points of time to symptomatic progression and time to initiation of cytotoxic chemotherapy for Akeega plus prednisone versus AAP alone. There was also a trend observed toward improvement in overall survival. "As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation," Kim Chi, M.D., the principal investigator of the phase 3 MAGNITUDE study, said in a statement.

Health Health Latest News, Health Health Headlines

Similar News:You can also read news stories similar to this one that we have collected from other news sources.

KFF Health News' 'What the Health?': Abortion pill’s legal limbo continuesA divided three-judge federal appeals court panel has ruled that a lower court was wrong to try to reverse entirely the FDA's approval of the abortion drug mifepristone.
Source: NewsMedical - 🏆 19. / 71 Read more »

Novel treatment based on gene editing safely and effectively removes HIV-like virus from genomes of non-human primatesA single injection of a novel CRISPR gene-editing treatment safely and efficiently removes SIV—a virus related to the AIDS-causing agent HIV—from the genomes of non-human primates, scientists at the Lewis Katz School of Medicine at Temple University now report. The groundbreaking work complements previous experiments as the basis for the first-ever clinical trial of an HIV gene-editing technology in human patients, which was authorized by the Food and Drug Administration (FDA) in 2022.
Source: medical_xpress - 🏆 101. / 51 Read more »

Care at high-volume radiation treatment centers tied to higher survivalAmong men with very high-risk prostate cancer, higher radiation facility case volume is independently associated with longer overall survival, according to a study published online Aug. 8 in JAMA Network Open.
Source: medical_xpress - 🏆 101. / 51 Read more »