FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLC Pooled analysis finds correlations between early endpoints and OS in ICI trials

FDA delays drug reviews in new voucher program amid safety, efficacy concerns

The reviews of two drugs granted priority review via FDA’s new priority voucher program, Commissioner’s National Priority Voucher (CNPV) Pilot Program, have been delayed.

January 30, 2026

By Claire Marie Porter

Clinical Roundup

Itismeran autogene + Keytruda demonstrated improvement in recurrence-free survival in neoadjuvant melanoma

Moderna and Merck announced median five-year follow-up data from the phase IIb KEYNOTE-942/mRNA-4157-P201 study, evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with high-risk melanoma (stage 3/4) following complete resection.

January 30, 2026

Drugs & Targets

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

FDA has approved Darzalez Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility.

January 30, 2026

Clinical

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

FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLC

Pooled analysis finds correlations between early endpoints and OS in ICI trials

YOU MAY BE INTERESTED IN

FDA delays drug reviews in new voucher program amid safety, efficacy concerns

Itismeran autogene + Keytruda demonstrated improvement in recurrence-free survival in neoadjuvant melanoma

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

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

Renew today!

Subscriber content

Never miss an issue!

Login

FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLC

Pooled analysis finds correlations between early endpoints and OS in ICI trials

YOU MAY BE INTERESTED IN

FDA delays drug reviews in new voucher program amid safety, efficacy concerns

Itismeran autogene + Keytruda demonstrated improvement in recurrence-free survival in neoadjuvant melanoma

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

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

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