FDA approved the application of erleada ® for prostate cancer by Janssen

J & J's Janssen Pharmaceutical Company today announced that the U.S Food and Drug Administration (FDA) has approved erleada ® (apalutamine) for the treatment of metastatic castration sensitive prostate cancer (mscspc) patients Today's approval follows the FDA's priority review regulations, and the FDA's real-time oncology review plan was reviewed and passed in April 2019 Supplementary new drug application (SNDA) submitted in June The new indications of erleada ® will allow this androgen receptor inhibitor to be used in patients with mscspc About 40000 people in the United States are diagnosed with mscspc every year Approval of new indications is based on the results of the phase 3 Titan study In the first preplanned interim analysis, the study found a statistically significant double primary end point for overall survival (OS) and progression free survival (RPFS) The extent of the patient's illness was not taken into account in the recruitment process The patients included patients with high volume and low volume diseases, and also had a history of docetaxel treatment Results the oral report of the annual meeting of the American Society of Clinical Oncology (ASCO) in 2019 was published in the New England Journal of medicine "Prostate cancer is harder to treat once it spreads It is clear that androgen deprivation therapy (ADT) alone is often not enough for patients with castration sensitive diseases " Dr Kim Chi, BC oncologist in cancer medicine, said he was also the lead researcher of Vancouver and Titan research: "the results of Titan research show that patients with metastatic castration sensitive prostate cancer may benefit from the treatment of apalutamine in addition to ADT, regardless of the degree of disease." In the Titan study, erleada ® combined with ADT significantly expanded the OS and reduced the risk of death by 33% (HR = 0.67; 95% CI, 0.51-0.89; P = 0.0053) compared to placebo plus ADT Compared with placebo plus ADT, erleada ® plus ADT also significantly improved RPFS, reducing the risk of radiologic progression or death by 52% (HR = 0.48; 95% CI, 0.39-0.60; P < 0.0001) After a median follow-up of 22.7 months, the results published in the Titan study reported a two-year OS rate of 84% for erleada ® in combination with ADT and 78% for placebo plus ADT "Erleada ® has the potential to change the way prostate cancer patients are treated by delaying disease progression and prolonging survival, regardless of the extent of the disease or the history of docetaxel treatment," said Margaret Yu bosh, regional head and vice president of prostate cancer disease at Janssen's R & D department We are committed to improving the standards of care for prostate cancer patients as we continue to develop innovative therapies in disease continuum " In randomized placebo-controlled clinical trials (Titan and Spartan), the most common adverse reactions (≥ 10%) in erleada ® treated patients (placebo group ≥ 2%) were fatigue, joint pain, rash, loss of appetite, falls, weight loss, hypertension, hot flashes, diarrhea and fractures (BIOON Com) original source: Janssen official website