FDA approves Opdualag for unresectable or metastatic melanoma

FDA debuts precheck manufacturing program to boost domestic drug development

FDA has launched a venture in onshoring domestic drug development called the Precheck Pilot Program.

February 06, 2026

Neoadjuvant pembrolizumab helps shrink tumors in patients with desmoplastic melanoma

In a recent multi-institutional clinical trial, 71% of patients who received the immunotherapy drug pembrolizumab, an anti-PD-1 immune checkpoint inhibitor, before surgery had no detectable cancer remaining at the time of surgery.

February 06, 2026

Vol.52 No.05

Drugs & Targets

FDA issues a boxed warning for capecitabine and fluorouracil on risks associated with DPD deficiency

FDA announced recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase deficiency.

February 06, 2026

Vol.52 No.05

Cancer Policy

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

Vol.52 No.04

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

Vol.52 No.04

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

Vol.52 No.04

FDA approves Opdualag for unresectable or metastatic melanoma

YOU MAY BE INTERESTED IN

FDA debuts precheck manufacturing program to boost domestic drug development

Neoadjuvant pembrolizumab helps shrink tumors in patients with desmoplastic melanoma

FDA issues a boxed warning for capecitabine and fluorouracil on risks associated with DPD deficiency

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

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