Cullinan Oncology, Taiho Pharmaceutical to develop and commercialize CLN-081/TAS6417 for NSCLC

FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials

FDA announced the final design of the Expedited Investigational New Drug Pilot.

September 18, 2026

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC

FDA has granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

September 18, 2026

Vol.52 No.34

Clinical Roundup

Zipalertinib + chemo meets primary endpoint in phase III REZILIENT3 trial in first-line EGFR exon 20 insertion mutation NSCLC

The REZILIENT3 trial, a global phase III clinical trial evaluating the combination of zipalertinib and platinum-based chemotherapy compared with chemotherapy alone in the first-line treatment of adult patients with previously untreated, locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations, met its primary endpoint of progression-free survival at a planned interim analysis.

September 11, 2026

Vol.52 No.33

Guest Editorial

The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and why
Drug development must convene a forum for candid, cross-sector discussion

At the 2026 Annual Meeting of the American Society of Clinical Oncology in Chicago, results from the phase III HARMONi-6 trial were presented at the plenary session and published simultaneously in The Lancet. The HARMONi-6 trial tested a novel bispecific antibody that engages PD-1 and VEGF (ivonescimab), given with platinum-doublet chemotherapy to patients with previously untreated advanced squamous non-small cell lung cancer.

August 14, 2026

Vol.52 No.32

By Richard L. Schilsky, H. Kim Lyerly, Thomas R. Fleming and Renzo Canetta

Clinical Guest Editorial

Marketing hope before surgery: Does the new Keytruda commercial tell patients the whole story?

A patient recently asked me a question I suspect many thoracic surgeons will soon be hearing.

August 07, 2026

Vol.52 No.31

By Raja Flores

Podcast

Pour a Scotch, we’re talking clinical trials and prediction markets

In last week’s issue of The Cancer Letter, the cover story featured coverage of Kalshi, an online prediction market exchange, launching a pilot program in which one can place bets on both outcomes of trials and FDA decisions.

August 05, 2026

Vol.52 No.31

Cullinan Oncology, Taiho Pharmaceutical to develop and commercialize CLN-081/TAS6417 for NSCLC

YOU MAY BE INTERESTED IN

FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC

Zipalertinib + chemo meets primary endpoint in phase III REZILIENT3 trial in first-line EGFR exon 20 insertion mutation NSCLC

The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and why
Drug development must convene a forum for candid, cross-sector discussion

Marketing hope before surgery: Does the new Keytruda commercial tell patients the whole story?

Pour a Scotch, we’re talking clinical trials and prediction markets

Renew today!

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Cullinan Oncology, Taiho Pharmaceutical to develop and commercialize CLN-081/TAS6417 for NSCLC

YOU MAY BE INTERESTED IN

FDA’s expedited IND pilot aims to shorten the timeline between drug development and first-in-human clinical trials

FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous NSCLC

Zipalertinib + chemo meets primary endpoint in phase III REZILIENT3 trial in first-line EGFR exon 20 insertion mutation NSCLC

The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and whyDrug development must convene a forum for candid, cross-sector discussion

Marketing hope before surgery: Does the new Keytruda commercial tell patients the whole story?

Pour a Scotch, we’re talking clinical trials and prediction markets

Never miss an issue!

Login

The defining question of the next decade is not how many drug candidates can be generated, but who decides which ones move forward, and why
Drug development must convene a forum for candid, cross-sector discussion