Glecirasib shows positive ORR for KRASG12C mutated-NSCLC in phase II trial

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

Drugs & Targets

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

FDA has granted Hyrnuo (sevabertinib) priority review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations in patients with no prior therapy.

May 22, 2026

Vol.52 No.20

Drugs & Targets

FDA accepts NDA for zipalertinib for NSCLC with mutations

FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.

May 01, 2026

Vol.52 No.17

Clinical

Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OS
PanCAN’s Berkenblit: “It’s here. This is a tipping point, and we’ve tipped. And this is just the beginning.”

The long-awaited results from the RASolute 302 trial—a phase III clinical trial evaluating daraxonrasib, a RAS inhibitor, for the treatment of patients with previously treated, metastatic pancreatic ductal adenocarcinoma—have been read out.

Nuvalent submits NDA to FDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC

Nuvalent announced the submission of a New Drug Application to FDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive non-small cell lung cancer.

April 10, 2026

Vol.52 No.14

Drugs & Targets

FDA approves Hernexeos as an initial treatment for HER2-mutant advanced NSCLC

FDA approved Hernexeos (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

February 27, 2026

Vol.52 No.08

Glecirasib shows positive ORR for KRASG12C mutated-NSCLC in phase II trial

YOU MAY BE INTERESTED IN

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

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

FDA accepts NDA for zipalertinib for NSCLC with mutations

Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OS
PanCAN’s Berkenblit: “It’s here. This is a tipping point, and we’ve tipped. And this is just the beginning.”

Nuvalent submits NDA to FDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC

FDA approves Hernexeos as an initial treatment for HER2-mutant advanced NSCLC

Renew today!

Subscriber content

Never miss an issue!

Login

Glecirasib shows positive ORR for KRASG12C mutated-NSCLC in phase II trial

YOU MAY BE INTERESTED IN

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

FDA grants priority review to Hyrnuo in first-line HER2-mutated NSCLC

FDA accepts NDA for zipalertinib for NSCLC with mutations

Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OSPanCAN’s Berkenblit: “It’s here. This is a tipping point, and we’ve tipped. And this is just the beginning.”

Nuvalent submits NDA to FDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC

FDA approves Hernexeos as an initial treatment for HER2-mutant advanced NSCLC

Never miss an issue!

Login

Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OS
PanCAN’s Berkenblit: “It’s here. This is a tipping point, and we’ve tipped. And this is just the beginning.”