FDA approval of IDE supplement to expand Alpha DaRT IMPACT Trial to patients with pancreatic cancer receiving gemcitabine with abraxane

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

Disappointment hangs in the air as Replimune’s Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab in the treatment of advanced melanoma was denied again by FDA on April 10.

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

The FDA Oncologic Drugs Advisory Committee on April 30 considered two applications from AstraZeneca Pharmaceuticals LP.

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

Drugs & Targets

FDA grants priority review for Ziihera in first-line HER2+ GEA

FDA has accepted for filing with Priority Review the supplemental Biologics License Application for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma.

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.

Experimental drug doubles one-year survival in pancreatic cancer trial, Northwestern study finds

Patients with pancreatic cancer who received the experimental drug elraglusib, alongside standard chemotherapy, were twice as likely to be alive after one year of treatment, compared to those receiving chemotherapy alone, according to the results of a randomized phase II clinical trial conducted by researchers at Northwestern University. The drug also reduced the risk of death by 38%.

April 17, 2026

Vol.52 No.15

FDA approval of IDE supplement to expand Alpha DaRT IMPACT Trial to patients with pancreatic cancer receiving gemcitabine with abraxane

YOU MAY BE INTERESTED IN

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

FDA accepts NDA for zipalertinib for NSCLC with mutations

FDA grants priority review for Ziihera in first-line HER2+ GEA

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.”

Experimental drug doubles one-year survival in pancreatic cancer trial, Northwestern study finds

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FDA approval of IDE supplement to expand Alpha DaRT IMPACT Trial to patients with pancreatic cancer receiving gemcitabine with abraxane

YOU MAY BE INTERESTED IN

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients“Patients are owed another review.”

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

FDA accepts NDA for zipalertinib for NSCLC with mutations

FDA grants priority review for Ziihera in first-line HER2+ GEA

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.”

Experimental drug doubles one-year survival in pancreatic cancer trial, Northwestern study finds

Never miss an issue!

Login

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

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.”