FDA and Telix have reached an agreement regarding resubmission of its New Drug Application for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer.
Vinay Prasad has regained his role as FDA’s chief medical and scientific officer, according to an update on the agency’s website.
FDA introduced the Rare Disease Evidence Principles to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.
FDA has approved gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.
FDA granted Breakthrough Therapy designation to Hernexeos (zongertinib tablets) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations.
FDA has granted Fast Track designation to CER-1236 for Acute Myeloid Leukemia. CER-1236 is a therapy that engineers a cancer patient’s own T-cell therapeutics that deploy phagocytic mechanisms alongside the array of built-in target cell destroying mechanisms used by T-cells.
The FDA’s Oncology Center of Excellence is inviting academic and patient advocate researchers to propose research questions for Project Collaborate, a crowdsourcing initiative running Sept. 2-26.
At the end of July, after just a few months as director of the Center for Biologics Evaluation and Research, Vinay Prasad resigned.
To fight drug shortages that have dogged all of medicine—including oncology—for decades, the Trump administration is returning to a policy it first enacted during the president’s first term.
FDA is shortening its timeline for publicizing Complete Response Letters, pledging to make them available to the public “promptly” after sponsors receive notice.
