FDA grants Breakthrough Therapy designation to elironrasib for lung cancer

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.

65% of eligible lung cancer patients do not receive the most appropriate targeted therapies

Diaceutics has released research revealing a critical shift in precision medicine. Despite major advances in biomarker testing, nearly two-thirds of eligible patients with advanced non-small cell lung cancer in the U.S. are still not receiving the most appropriate treatment.

May 01, 2026

Vol.52 No.17

Drugs & Targets

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

Cancer Policy

One year of reducing animal testing in drug development

FDA announced that it has achieved its first-year goals in implementing its roadmap to reduce animal testing in preclinical studies.

April 24, 2026

Vol.52 No.16

By Claire Marie Porter

FDA grants Breakthrough Therapy designation to elironrasib for lung cancer

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

65% of eligible lung cancer patients do not receive the most appropriate targeted therapies

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

One year of reducing animal testing in drug development

Renew today!

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FDA grants Breakthrough Therapy designation to elironrasib for lung cancer

YOU MAY BE INTERESTED IN

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

65% of eligible lung cancer patients do not receive the most appropriate targeted therapies

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

One year of reducing animal testing in drug development

Never miss an issue!

Login

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