FDA approves Imjudo + Imfinzi and platinum-based chemo for metastatic NSCLC

Breaking down Operation Trailblazer: Rolling INDs, outside expert submission help, and one-trial requirement

In this week’s episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Sara Willa Ernst, reporter, break down HHS’ latest vision for the future: Operation Trailblazer.

July 01, 2026

Cancer Policy

FDA advisory panel recommends first-of-its-kind mRNA flu vaccine for older adults

An FDA advisory panel has recommended approval of Moderna’s mRNA-based flu vaccine, mFlusiva, for adults ages 50-64, and adults 65 and older, if a specific condition is met.

June 26, 2026

Vol.52 No.25

By Claire Marie Porter

Clinical Roundup

Sigvotatug vedotin misses OS primary endpoint vs. docetaxel in phase III trial in previously treated metastatic non-squamous NSCLC

Sigvotatug vedotin, an integrin beta-6 directed antibody-drug conjugate, did not show a statistically significant improvement in the primary endpoint of overall survival, compared to docetaxel, according to the results of the phase III SigVie-002 study (previously known as Be6A Lung-01).

June 26, 2026

Vol.52 No.25

Drugs & Targets

FDA approves Tecelra for pediatric synovial sarcoma

FDA granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

June 26, 2026

Vol.52 No.25

Podcast

Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

In this week's episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher, and Sara Willa Ernst, reporter, go on a trip into the world of federal health policy surrounding psychedelic medicine.

June 24, 2026

Regulatory News

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

Earlier this year, Joe Rogan, host of “The Joe Rogan Experience” podcast, sent a text to President Donald Trump.

June 18, 2026

Vol.52 No.24

By Sara Willa Ernst

FDA approves Imjudo + Imfinzi and platinum-based chemo for metastatic NSCLC

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Breaking down Operation Trailblazer: Rolling INDs, outside expert submission help, and one-trial requirement

FDA advisory panel recommends first-of-its-kind mRNA flu vaccine for older adults

Sigvotatug vedotin misses OS primary endpoint vs. docetaxel in phase III trial in previously treated metastatic non-squamous NSCLC

FDA approves Tecelra for pediatric synovial sarcoma

Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

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FDA approves Imjudo + Imfinzi and platinum-based chemo for metastatic NSCLC

YOU MAY BE INTERESTED IN

Breaking down Operation Trailblazer: Rolling INDs, outside expert submission help, and one-trial requirement

FDA advisory panel recommends first-of-its-kind mRNA flu vaccine for older adults

Sigvotatug vedotin misses OS primary endpoint vs. docetaxel in phase III trial in previously treated metastatic non-squamous NSCLC

FDA approves Tecelra for pediatric synovial sarcoma

Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

Is psilocybin heading to a cancer clinic near you?Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

Never miss an issue!

Login

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research