FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

FDA approves Hernexeos as an initial treatment for HER2-mutant advanced NSCLC

FDA approved Hernexeos (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

February 27, 2026

Vol.52 No.08

Cancer Policy

At Friends meeting, Pazdur, Woodcock lament FDA’s failure to protect the agency staff from political interference, warn of “lasting implications”

For decades, FDA commissioners sought to insulate the agency’s professional staff from political interference with regulatory decisions.

By Jacquelyn Cobb and Claire Marie Porter

FDA approves pancreatic cancer device

FDA approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields, to the abdomen.

FDA grants Breakthrough Therapy designation to Rybrevant Faspro in advanced head-and-neck cancer

FDA granted Breakthrough Therapy designation for subcutaneous amivantamab and hyaluronidase-lpuj as a monotherapy for the treatment of adults with head-and-neck squamous cell carcinoma that is recurrent or metastatic and human papillomavirus-unrelated after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

FDA accepts NDA for iberdomide in patients with r/r MM

FDA accepted a New Drug Application for iberdomide combined with standard treatment, daratumumab + dexamethasone, (also called IberDd )in patients with relapsed or refractory multiple myeloma. Iberdomide is part of an investigational, new class of medicines called cereblon E3 ligase modulator agents. FDA has granted a Prescription Drug User Fee Act date of Aug. 17 for this indication.