FDA grants Ambrx Fast Track designation for prostate cancer ADC therapy

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized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

Adjuvant immunotherapy + hormone therapy may counteract immune-suppression in early-stage prostate cancer, Mayo-led study finds

Pairing a next-generation immunotherapy with standard hormone therapy before surgery may help overcome a long-standing barrier in early-stage prostate cancer treatment, according to a Mayo Clinic-led study.

February 27, 2026

Vol.52 No.08

Clinical Roundup

Androgen receptor alterations in bloodwork linked to poorer outcomes across therapies treating metastatic prostate cancer

Androgen receptor alterations consistently emerged in serial liquid biopsies researchers used to track how metastatic prostate cancer evolves under treatment pressure. These alterations were linked to poorer outcomes across therapies, according to a multi-center collaboration of investigators from Sylvester, UC San Diego, Moores Cancer Center, the University of California, San Francisco, Scripps Research Institute, and Guardant Health.

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

FDA grants Ambrx Fast Track designation for prostate cancer ADC therapy

YOU MAY BE INTERESTED IN

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

Adjuvant immunotherapy + hormone therapy may counteract immune-suppression in early-stage prostate cancer, Mayo-led study finds

Androgen receptor alterations in bloodwork linked to poorer outcomes across therapies treating metastatic prostate 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”

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