Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population

The FDA Oncologic Drugs Advisory Committee July 17 recommended against approval of a Blenrep-based regimen for the treatment of relapsed or refractory multiple myeloma, citing unacceptable rates of ocular toxicity and overall poor tolerability of the drug.

July 18, 2025

Vol.51 No.28

By Jacquelyn Cobb and Sara Willa Ernst

Imaging’s ride to the bottom in clinical trials—and why it matters now

In cancer care, imaging has become a marvel of modern medicine. Advances in scanner technology, reconstruction algorithms, contrast agents, and diagnostic protocols have radically improved our ability to detect, track, and understand disease. Clinically, imaging is fast, accurate, and central to decision-making.

NIH says it’s moving away from animal-based models

NIH has announced that it will no longer be issuing Notices of Funding Opportunities exclusively supporting animal models.

July 18, 2025

Vol.51 No.28

By Claire Marie Porter

Clinical Roundup

Xtandi + ADT slow disease-progression in mHSPC compared to darolutamide + ADT

Xtandi (enzalutamide) plus ADT significantly slows disease progression vs darolutamide plus ADT in patients with mHSPC, according to a matching-adjusted indirect comparison analysis published in Future Oncology.

July 18, 2025

Vol.51 No.28

Drugs & Targets

FDA gives TAR-200 Priority Review for invasive bladder cancer

FDA has granted Priority Review to TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

July 18, 2025

Vol.51 No.28

In the Archives

Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

The Pazdurs in their garden with their dog, Cleo. The dog’s full name is Cleopatra, Queen of Denial.In 1999, Rick Pazdur went in for a “perfunctory” final interview at FDA. Thinking it would only take a few minutes, his wife, Mary, decided to wait and have a quick cup of coffee at a nearby restaurant—Hooters.

July 11, 2025

Vol.51 No.27

By Katie Goldberg

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

YOU MAY BE INTERESTED IN

ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population

Imaging’s ride to the bottom in clinical trials—and why it matters now

NIH says it’s moving away from animal-based models

Xtandi + ADT slow disease-progression in mHSPC compared to darolutamide + ADT

FDA gives TAR-200 Priority Review for invasive bladder cancer

Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

Renew today!

Subscriber content

Never miss an issue!

Login

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

YOU MAY BE INTERESTED IN

ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population

Imaging’s ride to the bottom in clinical trials—and why it matters now

NIH says it’s moving away from animal-based models

Xtandi + ADT slow disease-progression in mHSPC compared to darolutamide + ADT

FDA gives TAR-200 Priority Review for invasive bladder cancer

Rick and Mary Pazdur on facing “the other side of the stethoscope”A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology

Never miss an issue!

Login

Rick and Mary Pazdur on facing “the other side of the stethoscope”
A few months before Mary died of ovarian cancer, the couple shared how this experience shaped their perspectives on oncology