Erleada is ninth product known to be using US FDA’s Real-Time Oncology Review pilot program, as shown in our comprehensive chart.
Johnson & Johnson advanced its strategy of moving Erleada (apalutamide) into earlier stages of prostate cancer with a supplemental new drug application submission for treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) announced on 29 April 2019.
The company is hoping for approval “as soon as possible” thanks to the US Food and Drug Administration’s Real-Time Oncology Review (RTOR) pilot program. The pilot program aims to speed...
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
