After two delays spanning more than a year, Novartis is finally gearing up for a high-stakes FDA application to expand the radiotherapy Pluvicto into earlier treatment of prostate cancer.Novartis made the decision after patient survival data turned in Pluvicto’s favor at another preplanned analysis of the phase 3 PSMAfore trial.

经过两次长达一年多的延迟，诺华终于准备向FDA提交高风险的申请，将放射治疗Pluvicto扩展到前列腺癌的早期治疗。诺华是在患者生存数据在另一项预先计划的3期PSMAfore试验分析中对Pluvicto有利后做出这一决定的。

The study is pitting the drug against a change of androgen receptor inhibitor in patients with PSMA-positive, metastatic castration-resistant prostate cancer who hadn’t received chemotherapy.The updated result now includes 75% of deaths before the final analysis of overall survival. Previously, when the trial had accrued 45% of death events, a preliminary trend linked Pluvicto to a 16% increased risk of death before adjusting for patient crossovers.Leaping into the pre-chemo setting is key in Novartis’ $3 billion-plus peak sales estimate for Pluvicto, which is currently approved for patients after failure on chemotherapy.In a Thursday press release, Novartis said it plans to file Pluvicto for a pre-chemo approval in the second half of 2024.

这项研究旨在对抗未接受化疗的PSMA阳性转移性去势抵抗性前列腺癌患者雄激素受体抑制剂的变化。在最终分析总体生存之前，更新的结果现在包括75%的死亡。此前，当试验累积了45%的死亡事件时，在调整患者交叉之前，初步趋势将Pluvicto与死亡风险增加16%联系起来。进入化疗前环境是诺华对Pluvicto的30多亿美元峰值销售额估计的关键，目前该估计已被批准用于化疗失败后的患者。诺华在周四的新闻稿中表示，计划在2024年下半年将Pluvicto提交化疗前批准。

That leaves another three months at a minimum if the company should file first thing in July. The gap is a bit long considering that the application has already been delayed twice because of immature data. Novartis has been preparing for this day all this time, having expressed much confidence in the 75% data cut.RelatedNovartis' Zolgensma, Leqvio lag among new launches as Entresto and Pluvicto steam aheadAlthough the level of death risks has now flipped between the two trial arms in PSMAfore, question remains as to whether the current positive overall survival trend, at 75% maturity, is strong enough to convince the FDA that it’s sustainable or if it’s just a transient spark.In response to a Fierce Pharma in.

如果该公司在7月份首先提交文件，那么至少还有三个月的时间。考虑到由于数据不成熟，应用程序已经延迟了两次，差距有点长。诺华一直在为这一天做准备，对75%的数据削减表示了很大的信心。诺华（Novartis）旗下的佐尔根斯玛（Zolgensma）和莱克维奥（Leqvio）在Entresto和Pluvicto steam Ahead等新推出的产品中处于落后地位。尽管死亡风险水平现在在PSMAfore的两个试验部门之间发生了翻转，但目前75%成熟度的积极总体生存趋势是否足以说服美国食品和药物管理局（FDA）相信它是可持续的，或者它只是一个短暂的火花。为了应对年一家激烈的制药公司。