ODAC says prostate cancer patients who lack proven BRCA mutation shouldn’t get PARP inhibitor

Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

The Friends of Cancer Research annual meeting, to be held Nov. 4 in Washington, DC, will focus on three questions facing the field of oncology clinical trial design.

FDA publishes draft guidance to accelerate biosimilar development and lower costs

In a new draft guidance, FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.

October 31, 2025

Vol.51 No.40

Cancer Policy

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Earlier this year, FDA announced that it would be initiating a voucher program aimed at accelerating review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, June 20, 2025).

October 24, 2025

Vol.51 No.39

By Claire Marie Porter

Clinical Roundup

GammaTile delivers superior tumor control vs. standard-of-care for newly diagnosed operable brain metastases

GammaTile showed superiority in the primary endpoint of the study. Patients who received GammaTile lived longer without tumor regrowth, reducing the risk of either tumor recurrence or death by 50% reduction compared to standard of care, according to interim results from the ROADS clinical trial, which evaluated GammaTile versus standard of care in patients with operable, newly diagnosed brain metastases.

October 24, 2025

Vol.51 No.39

Clinical Roundup

Enzalutamide drug combination cuts risk of death in advanced prostate cancer, Cedars-Sinai-led study shows

Men whose prostate cancer returns after surgery or radiation therapy may now benefit from a new drug combination shown in clinical trials to cut the risk of death by more than 40%.

October 24, 2025

Vol.51 No.39

Clinical Regulatory News Trials & Tribulations

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL).

October 17, 2025

Vol.51 No.38

By Edison T. Liu

ODAC says prostate cancer patients who lack proven BRCA mutation shouldn’t get PARP inhibitor

YOU MAY BE INTERESTED IN

Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

FDA publishes draft guidance to accelerate biosimilar development and lower costs

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

GammaTile delivers superior tumor control vs. standard-of-care for newly diagnosed operable brain metastases

Enzalutamide drug combination cuts risk of death in advanced prostate cancer, Cedars-Sinai-led study shows

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

Renew today!

Subscriber content

Never miss an issue!

Login

ODAC says prostate cancer patients who lack proven BRCA mutation shouldn’t get PARP inhibitor

YOU MAY BE INTERESTED IN

Friends publishes three white papers ahead of annual meetingTopics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

FDA publishes draft guidance to accelerate biosimilar development and lower costs

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

GammaTile delivers superior tumor control vs. standard-of-care for newly diagnosed operable brain metastases

Enzalutamide drug combination cuts risk of death in advanced prostate cancer, Cedars-Sinai-led study shows

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

Never miss an issue!

Login

Friends publishes three white papers ahead of annual meeting
Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies