EU CHMP adopts positive opinion for Cabometyx in radioactive iodine-refractory differentiated thyroid cancer

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

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

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

Drugs & Targets

FDA approves Komzifti for r/r NPM1-mutated AML

FDA has granted full approval of Komzifti (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Komzifti is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated AML, a devastating blood cancer with limited treatment options.

November 14, 2025

Vol.51 No.42

Cancer Policy

Zongertinib, dostarlimab chosen in second batch of National Priority Vouchers recipients

FDA announced six additional awardees under the Commissioner’s National Priority Voucher pilot program, which aims to accelerate review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, Oct. 24, June 20, 2025).

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

FDA approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

October 24, 2025

Vol.51 No.39

EU CHMP adopts positive opinion for Cabometyx in radioactive iodine-refractory differentiated thyroid cancer

YOU MAY BE INTERESTED IN

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

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

FDA approves Komzifti for r/r NPM1-mutated AML

Zongertinib, dostarlimab chosen in second batch of National Priority Vouchers recipients

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

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EU CHMP adopts positive opinion for Cabometyx in radioactive iodine-refractory differentiated thyroid cancer

YOU MAY BE INTERESTED IN

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

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

FDA approves Komzifti for r/r NPM1-mutated AML

Zongertinib, dostarlimab chosen in second batch of National Priority Vouchers recipients

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

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