First FDA-approved robot-assisted microsurgery for head-and-neck cancer performed at Cedars-Sinai

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations.

February 27, 2026

Vol.52 No.08

Clinical Roundup

Rybrevant Faspro + immunotherapy shows strong clinical benefit for recurrent or metastatic head-and-neck cancer

Data from the phase Ib/II OrigAMI-4 study found that first-line treatment with investigational subcutaneous amivantamab and hyaluronidase-lpuj in combination with a PD-1 inhibitor delivered clinically meaningful and durable antitumor activity in patients with head and neck squamous cell carcinoma that is recurrent or metastatic, PD-L1-positive, and HPV-unrelated.

February 27, 2026

Vol.52 No.08

Drugs & Targets

FDA approves Braftovi combination regimen in first-line metastatic colorectal cancer

FDA granted full approval to Braftovi (encorafenib) in combination with cetuximab (Erbitux) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation based on results from the global phase III BREAKWATER trial.

February 27, 2026

Vol.52 No.08

Drugs & Targets

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.

February 20, 2026

Vol.52 No.07

By Jacquelyn Cobb and Claire Marie Porter

Drugs & Targets

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.

February 20, 2026

Vol.52 No.07

First FDA-approved robot-assisted microsurgery for head-and-neck cancer performed at Cedars-Sinai

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FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

Rybrevant Faspro + immunotherapy shows strong clinical benefit for recurrent or metastatic head-and-neck cancer

FDA approves Braftovi combination regimen in first-line metastatic colorectal cancer

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

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

FDA approves pancreatic cancer device

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