Of adaptive and factorial designs A biostatistician’s interpretation of last week’s ODAC

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

A story is told that after first obtaining approval for marketing Premarin in 1942, Wyeth Laboratories didn’t lock up the secret recipe for making the hormonal drug in a company safe, to be guarded by patent lawyers.

January 23, 2026

Vol.52 No.03

By Claire Marie Porter

Clinical Roundup

Trodelvy + Keytruda show potential as new standard of care in first-line PD-L1+ metastatic TNBC, phase III trial finds

Patients saw a 35% reduced risk of disease progression or death for Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) (n=221) versus standard of care Keytruda plus chemotherapy (n=222), according to the positive phase III ASCENT-04/KEYNOTE-D19 study evaluating the combination of Trodelvy plus Keytruda in first-line PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer.

January 23, 2026

Vol.52 No.03

Clinical Roundup

Sylvester-led study focuses on rate of failure in head and neck cancer trials

Researchers from Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and collaborators analyzed 692 clinical trials launched between 2000 and 2024.

January 23, 2026

Vol.52 No.03

Drugs & Targets

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

FDA has issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease and complete response as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations.

January 23, 2026

Vol.52 No.03

Guest Editorial

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care

By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...

January 16, 2026

Vol.52 No.02

By Mark J. Ratain and David A. Hyman

Cancer Policy

FDA releases 10 guiding principles for AI use in drug development

FDA, in collaboration with the European Medicines Agency, has published 10 principles to help guide pharmaceutical companies using artificial intelligence to develop drug, biological, and medical devices.

January 16, 2026

Vol.52 No.02

By Sara Willa Ernst

Of adaptive and factorial designs

A biostatistician’s interpretation of last week’s ODAC

YOU MAY BE INTERESTED IN

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

Trodelvy + Keytruda show potential as new standard of care in first-line PD-L1+ metastatic TNBC, phase III trial finds

Sylvester-led study focuses on rate of failure in head and neck cancer trials

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care

FDA releases 10 guiding principles for AI use in drug development

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Of adaptive and factorial designs

A biostatistician’s interpretation of last week’s ODAC

YOU MAY BE INTERESTED IN

Premarin’s 84-year hold on the market ends as FDA approves a generic versionTrade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

Trodelvy + Keytruda show potential as new standard of care in first-line PD-L1+ metastatic TNBC, phase III trial finds

Sylvester-led study focuses on rate of failure in head and neck cancer trials

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

When “safe and effective” is not “reasonable and necessary”We can curb excessive drug dosing and improve the quality of cancer care

FDA releases 10 guiding principles for AI use in drug development

Never miss an issue!

Login

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

When “safe and effective” is not “reasonable and necessary”
We can curb excessive drug dosing and improve the quality of cancer care